Trials in healthy subjects

Report Year

Trial Code

Trial Title

Clinicaltrials.gov

EudraCTno.

Source

2017

LP0053-1276

Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle

NCT02973776

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar®

Formulation

foam

Trial Phase

1

Population

adults

2017

LP0084-1230

A randomized, controlled study to evaluate the sensitizing potential of LEO 43204 gel and gel vehicle in healthy volunteers using a repeat insult patch test design

NCT02650505

N/A

Summary

Active Substance

ingenol disoxate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

2017

 

LP0058-1267

 

A phase 1 drug-drug interaction study with LEO32731 and midazolam in healthy male subjects

NCT02753218

2015-005073-20

Summary

Active Substance

LEO 32731

LEO Pharma Product

N/A

Formulation

tablet

Trial Phase

1

Population

adults

2016

LP0058-1114

LEO 32731 - A Phase I, single-blind, placebo-controlled, single and multiple oral dose, safety, tolerability and pharmacokinetic study in healthy subjects

NCT02514694

2014-003337-25

Summary

Active Substance

LEO 32731

LEO Pharma Product

N/A

Formulation

tablet & capsule

Trial Phase

1

Population

adults

2016

LP0076-1080

Skin irritation test of LEO 80185 gel (calcipotriol hydrate plus betamethasone dipropionate) in healthy Japanese subjects

NCT02379793

N/A

Summary

Report

 

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2015

EXP-1090

A single-centre, explorative, randomised, investigator-blinded, negative-controlled, phase I clinical trial with intra-individual comparison of treatments to assess steroid induced skin atrophy on healthy skin

NCT02355639

2014-001450-42

Summary

Active Substance

N/A

LEO Pharma Product

N/A

Formulation

ointment

Trial Phase

1

Population

adults

2015

LP0058-1005

LP0058-1005 - A phase 1, open-label, four-way crossover and food-effect study of LEO 32731 in healthy subjects when administered as an immediate and modified release formulation

NCT02126371

2013-004346-41

Summary

Active Substance

LEO 32731

LEO Pharma Product

N/A

Formulation

tablet & capsule

Trial Phase

1

Population

adults

2015

SKAT-1129

A single-centre, prospective, randomised, investigator-blinded, vehicle-controlled, phase I clinical trial with intra-individual comparison of treatments to assess the potential of LEO 130852A gel to reduce steroid induced skin atrophy on healthy skin

NCT02392130

2014-003677

Summary

Active Substance

N/A

LEO Pharma Product

N/A

Formulation

ointment

Trial Phase

1

Population

adults

2014

LP0053-66

Combined cumulative irritation potential and repeat insult patch test of LEO 90100 areosol foam

NCT01935869

2012-004264-21

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar®

Formulation

foam

Trial Phase

1

Population

adults

2014

LP0053-69

A vasoconstriction study with LEO 90100

NCT01946386

2012-002660-28

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar® & Daivobet®

Formulation

foam & ointment

Trial Phase

1

Population

adults

2011

LP0041-01

PEP005 gel – evaluation of local tolerability after exposure to ingenol mebutate 0.05% and 0.015% gel followed by hand washing in healthy subjects

NCT01302925

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

1

Population

Adults

2011

MCB 0902

Multiple dose study of LEO 90105 – calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)

NCT01293383

2014-003677

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2011

MCB 0901

Skin irritation test of LEO 90105 – calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)

NCT01293357

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. & calcipotriol

LEO Pharma Product

Daivobet® & Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

1

Population

adults

2010

MCO 0901 FR

An irritation study with new calcipotriol ointment formulations in healthy subjects

NCT01105234

2009-017394-38

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

cream

Trial Phase

1

Population

adults

2009

PEP005-024

A randomized, controlled study to evaluate the photoallergic potential of PEP005 (ingenol mebutate) gel, 0.01% in healthy volunteers using an open application photoallergic test design

NCT00850681

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

2009

PEP005-023

A randomized, controlled study to evaluate the sensitizing ootential of PEP005 topical gel (0.01% concentration) in healthy volunteers using a repeat insult patch test design

NCT00850811

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

2008

CE 0701 DK

Single dose bioequivalence study of Centyl® K, LEO new tablet formulation vs. existing formulation of Centyl® K in healthy subjects of either sex

N/A

2007-005987-29

Summary

Report

Active Substance

bendroflumethiazide + potassium chloride

LEO Pharma Product

Centryl® K & Centryl® K Mite

Formulation

tablet

Trial Phase

1

Population

adults

2007

MBL 0501 FR

In vivo bioequivalence study of betamethasone dipropionate in Daivobet/Dovobet gel and Diprosone lotion according to FDA guideline for vasoconstrictor bioassay

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2007

MBL 0601 FR

Assessment of the atrophogenic potential and dermal tolerance of Daivobet/Dovobet gel compared with Diprosone® ointment

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2007

MBL 0403 FR

In vivo bioequivalence study of betamethasone dipropionate in Daivobet/Dovobet gel and Diprosone ointment according to FDA guideline for vasoconstrictor bioassay

N/A

2004-000036-84

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2007

OA 0402 DE

A phase I pharmacokinetic study with repeated doses of alfacalcidol in patients with chronic renal failure undergoing haemodialysis

N/A

2004-004379-12

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

One-Alpha®

Formulation

capsule

Trial Phase

1

Population

adults

2006

MBL 0402 UK

Assessment of the atrophogenic potential and dermal tolerance of Daivobet/Dovobet gel compared with Diprosone® ointment

N/A

2005-001 225-29

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2006

PEP005-005

A randomized, controlled study to evaluate the sensitizing ootential of PEP005 topical gel (0.01% concentration) in healthy volunteers using a repeat insult patch test design

NCT00357916

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

gel

Formulation

gel

Trial Phase

1

Population

adults

2006

MBL 0302 FR

Repeat insult patch test with Daivobet/Dovobet gel including 21-days cumulative irritation study and sensitisation potential in 200 healthy subjects

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2006

MBL 0301 UK

Assessment of the photosensitisation potential of Daivobet/Dovobet gel containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)

N/A

2005-001226-91

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2006

OA 0401 CA

A bioavailability study to assess the bioequivalence of alfacalcidol capsule and oral drop formulations: A comparative, randomized, single-dose, 4-way crossover bioavailability study of LEO Pharma A/S alfacalcidol (One-Alpha®) capsules and oral drops following a dose of 10 µg in healthy adult volunteers under fasting conditions

N/A

N/A

Summary

Report

Active Substance

alfacalcidol

LEO Pharma Product

One-Alpha®

Formulation

capsule & oral drops

Trial Phase

1

Population

adults

2005

MBL 0303 FR

Phototoxicity study: Assessment of the phototoxic potential of Daivobet/Dovobet (calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) gel

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2005

OA 0403 CA

A bioavailability study to investigate food interaction with a single dose of alfacalcidol: A comparative, randomized, single-dose, 3-way crossover, food effect and absolute bioavailability study of LEO Pharma alfacalcidol (One-Alpha®) following a dose of 10 μg in healthy adult volunteers

N/A

N/A

Summary

Report

Active Substance

alfacalcidol

LEO Pharma Product

One-Alpha®

Formulation

capsule & injectional solution

Trial Phase

1

Population

adults

2004

MCB 0306 UK

Daivobet/Dovobet ointment / UV penetration study in humans - detection of erythema induced by UV light, a within subject comparison of investigational materials against untreated skin

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. &calcipotriol

LEO Pharma Product

Daivobet® & Daivonex®/ Dovonex®

Formulation

ointment & scalp solution

Trial Phase

1

Population

adults

2003

MCB 0202 FR

Repeat insult patch test with Daivobet / Dovobet ointment - a study on the sensitisation potential of Daivobet / Dovobet ointment and the ointment vehicle when applied on healthy skin in 200 healthy subjects

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2003

MCB 0204 FR

Photo-allergy test: Assessment of the photosensitisation potential of Daivobet/Dovobet ointment (calcipotriol 50 µg/g and betamethasone (as dipropionate) 0.5 mg/g)

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2003

MCB 0203 FR

21-day cumulative irritation test: Assessment of the local skin tolerability, after repeated application of Daivobet/Dovobet ointment (calcipotriol 50 µg/g and betamethasone (as dipropionate) 0.5 mg/g)

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2002

MCB 0101 FR

Photo-toxicity study: Assessment of the phototoxic potential of Daivobet®/Dovobet® ointment (betamethasone dipropionate 0.5mg/g and calcipotriol 50μg/g)

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2001

MCO 9407 CA

Atrophogenic potential of calcipotriol, betamethasone and mometasone

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

1

Population

adults

2000

IN 9801 FR

An open (uncontrolled) clinical phase I study to assess the pharmacokinetic profile of tinzaparin (innohep®, LEO) after multiple subcutaneous doses in healthy male volunteers

N/A

N/A

Summary

Report

Active Substance

tinzaparin

LEO Pharma Product

innohep®

Formulation

injectional solution

Trial Phase

1

Population

adults

1999

MET 9802 FR

A comparative single dose bioavailability study of mecillinam in eighteen healthy male volunteers following oral administration of a new 400 mg pivmecillinam tablet versus oral administration of two 200 mg pivmecillinam tablets.

N/A

N/A

Summary

Report

Active Substance

pivmecillinam

LEO Pharma Product

Selexid®

Formulation

tablet

Trial Phase

1

Population

adults

1998

BUN 9403 DE

Bioavailability of 2 mg formulations for nasal and rectal administration of bumetanide

N/A

N/A

Summary

Report

Active Substance

bumetanide

LEO Pharma Product

Burinex®

Formulation

spray, suppositorie, tablet & injectional solution

Trial Phase

1

Population

adults

1998

FUT 9407 FR

Diffusion of fusidic acid, oxacillin and pristinamycin in interstitial dermal liquid

N/A

N/A

Summary

Report

Active Substance

sodium fusidate

LEO Pharma Product

Fucidin®

Formulation

tablet

Trial Phase

1

Population

adults

1998

MCO 9701 NL

Calcipotriol ointment and cream and the minimal erythema dose

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

ointment & cream

Trial Phase

1

Population

adults

1998

MCW 9702 UK

(3H)-MC 903 (calcipotriol scalp solution II): A study of percutaneous absorption and excretion following topical administration to healthy male volunteers

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

scalp solution

Trial Phase

1

Population

adults

1997

FUS 9602 UK

Evaluation of the bioavailability of a new oral suspension of fusidic acid versus a dry granulated, film coated tablet of sodium fusidate in healthy volunteers.”)

N/A

N/A

Summary

Report

Active Substance

fusidic acid & sodium fusidate

LEO Pharma Product

Fucidin®

Formulation

oral suspension & tablet

Trial Phase

1

Population

adults

1996

FU 192 CA / FPC191

Evaluation of the pharmacokinetics of fusidic acid in healthy volunteers

N/A

N/A

Summary

Report

Active Substance

sodium fusidate

LEO Pharma Product

Fucidin®

Formulation

tablet

Trial Phase

1

Population

adults

1996

FU 192

Evaluation of the bioavailability of wet granulated film coated and a dry granulated, film coated tablet of sodium fusidate in healthy volunteers

N/A

N/A

Summary

Report

Active Substance

sodium fusidate

LEO Pharma Product

Fucidin®

Formulation

tablet

Trial Phase

1

Population

adults

1995

BUT 9401 NL

Evaluation of the bioavailability of a 0.5 mg tablet of bumetanide in healthy volunteers

N/A

N/A

Summary

Report

Active Substance

bumetanide

LEO Pharma Product

Burinex®

Formulation

tablet

Trial Phase

1

Population

adults

1994

BU 9302 CA

Evaluation of the bioavailability of a 2 mg tablet of bumetanide in healthy volunteers

N/A

N/A

Summary

Report

Active Substance

bumetanide

LEO Pharma Product

Burinex®

Formulation

tablet

Trial Phase

1

Population

adults

1993

BU 9301 F

Absolute bioavailability of bumetanide after intramuscular injection: a randomized, open, cross-over study comparing bumetanide (2 mg I 4 ml) administered by I.V. or I.M. route in normal healthy

N/A

N/A

Summary

Report

Active Substance

bumetanide

LEO Pharma Product

Burinex®

Formulation

injectional solution

Trial Phase

1

Population

adults

1993

FUC 390 F

Pharmacokinetic study of oral fusidic acid (formulation: film-coated tablet) after the first dose and repeated doses in elderly subjects

N/A

N/A

Summary

Report

Active Substance

sodium fusidate

LEO Pharma Product

Fucidin®

Formulation

tablet

Trial Phase

1

Population

elderly

1992

KM 191 F

Comparison of intragastric dispersion for two solid forms of microencapsulated potassium chloride (tablet and capsule)

N/A

N/A

Summary

Report

Active Substance

sodium fusidate

LEO Pharma Product

N/A

Formulation

tablet & capsule

Trial Phase

1

Population

elderly

1992

KM 190 F

Comparison of intragastric PD variations caused by the administration of potassium chloride

N/A

N/A

Summary

Report

Active Substance

sodium fusidate

LEO Pharma Product

N/A

Formulation

solution, tablet & capsule

Trial Phase

1

Population

adults

1990

BUR 190 NL

A single dose bioequivalence study on bumetanide tablets: 1 x 5 mg Burinex® tablets (Leo Pharmaceutical Products B.V.) compared with 5 x 1 mg Burinex® tablets (Leo Pharmaceutical Products B.V.)

N/A

N/A

Summary

Report

Active Substance

bumetanide

LEO Pharma Product

Burinex®

Formulation

tablet

Trial Phase

1

Population

adults

 

Report Year

Trial Code

Trial Title

Clinicaltrials.gov

EudraCTno.

Source

2017

LP0053-1276

Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle

NCT02973776

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar®

Formulation

foam

Trial Phase

1

Population

adults

2017

LP0084-1230

A randomized, controlled study to evaluate the sensitizing potential of LEO 43204 gel and gel vehicle in healthy volunteers using a repeat insult patch test design

NCT02650505

N/A

Summary

Active Substance

ingenol disoxate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

2017

 

LP0058-1267

 

A phase 1 drug-drug interaction study with LEO32731 and midazolam in healthy male subjects

NCT02753218

2015-005073-20

Summary

Active Substance

LEO 32731

LEO Pharma Product

N/A

Formulation

tablet

Trial Phase

1

Population

adults

2016

LP0058-1114

LEO 32731 - A Phase I, single-blind, placebo-controlled, single and multiple oral dose, safety, tolerability and pharmacokinetic study in healthy subjects

NCT02514694

2014-003337-25

Summary

Active Substance

LEO 32731

LEO Pharma Product

N/A

Formulation

tablet & capsule

Trial Phase

1

Population

adults

2016

LP0076-1080

Skin irritation test of LEO 80185 gel (calcipotriol hydrate plus betamethasone dipropionate) in healthy Japanese subjects

NCT02379793

N/A

Summary

Report

 

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2015

EXP-1090

A single-centre, explorative, randomised, investigator-blinded, negative-controlled, phase I clinical trial with intra-individual comparison of treatments to assess steroid induced skin atrophy on healthy skin

NCT02355639

2014-001450-42

Summary

Active Substance

N/A

LEO Pharma Product

N/A

Formulation

ointment

Trial Phase

1

Population

adults

2015

LP0058-1005

LP0058-1005 - A phase 1, open-label, four-way crossover and food-effect study of LEO 32731 in healthy subjects when administered as an immediate and modified release formulation

NCT02126371

2013-004346-41

Summary

Active Substance

LEO 32731

LEO Pharma Product

N/A

Formulation

tablet & capsule

Trial Phase

1

Population

adults

2015

SKAT-1129

A single-centre, prospective, randomised, investigator-blinded, vehicle-controlled, phase I clinical trial with intra-individual comparison of treatments to assess the potential of LEO 130852A gel to reduce steroid induced skin atrophy on healthy skin

NCT02392130

2014-003677

Summary

Active Substance

N/A

LEO Pharma Product

N/A

Formulation

ointment

Trial Phase

1

Population

adults

2014

LP0053-66

Combined cumulative irritation potential and repeat insult patch test of LEO 90100 areosol foam

NCT01935869

2012-004264-21

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar®

Formulation

foam

Trial Phase

1

Population

adults

2014

LP0053-69

A vasoconstriction study with LEO 90100

NCT01946386

2012-002660-28

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar® & Daivobet®

Formulation

foam & ointment

Trial Phase

1

Population

adults

2011

LP0041-01

PEP005 gel – evaluation of local tolerability after exposure to ingenol mebutate 0.05% and 0.015% gel followed by hand washing in healthy subjects

NCT01302925

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

Picato®

Formulation

gel

Trial Phase

1

Population

Adults

2011

MCB 0902

Multiple dose study of LEO 90105 – calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)

NCT01293383

2014-003677

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2011

MCB 0901

Skin irritation test of LEO 90105 – calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)

NCT01293357

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. & calcipotriol

LEO Pharma Product

Daivobet® & Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

1

Population

adults

2010

MCO 0901 FR

An irritation study with new calcipotriol ointment formulations in healthy subjects

NCT01105234

2009-017394-38

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

cream

Trial Phase

1

Population

adults

2009

PEP005-024

A randomized, controlled study to evaluate the photoallergic potential of PEP005 (ingenol mebutate) gel, 0.01% in healthy volunteers using an open application photoallergic test design

NCT00850681

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

2009

PEP005-023

A randomized, controlled study to evaluate the sensitizing ootential of PEP005 topical gel (0.01% concentration) in healthy volunteers using a repeat insult patch test design

NCT00850811

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

1

Population

adults

2008

CE 0701 DK

Single dose bioequivalence study of Centyl® K, LEO new tablet formulation vs. existing formulation of Centyl® K in healthy subjects of either sex

N/A

2007-005987-29

Summary

Report

Active Substance

bendroflumethiazide + potassium chloride

LEO Pharma Product

Centryl® K & Centryl® K Mite

Formulation

tablet

Trial Phase

1

Population

adults

2007

MBL 0501 FR

In vivo bioequivalence study of betamethasone dipropionate in Daivobet/Dovobet gel and Diprosone lotion according to FDA guideline for vasoconstrictor bioassay

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2007

MBL 0601 FR

Assessment of the atrophogenic potential and dermal tolerance of Daivobet/Dovobet gel compared with Diprosone® ointment

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2007

MBL 0403 FR

In vivo bioequivalence study of betamethasone dipropionate in Daivobet/Dovobet gel and Diprosone ointment according to FDA guideline for vasoconstrictor bioassay

N/A

2004-000036-84

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2007

OA 0402 DE

A phase I pharmacokinetic study with repeated doses of alfacalcidol in patients with chronic renal failure undergoing haemodialysis

N/A

2004-004379-12

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

One-Alpha®

Formulation

capsule

Trial Phase

1

Population

adults

2006

MBL 0402 UK

Assessment of the atrophogenic potential and dermal tolerance of Daivobet/Dovobet gel compared with Diprosone® ointment

N/A

2005-001 225-29

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2006

PEP005-005

A randomized, controlled study to evaluate the sensitizing ootential of PEP005 topical gel (0.01% concentration) in healthy volunteers using a repeat insult patch test design

NCT00357916

N/A

Summary

Report

Active Substance

ingenol mebutate

LEO Pharma Product

gel

Formulation

gel

Trial Phase

1

Population

adults

2006

MBL 0302 FR

Repeat insult patch test with Daivobet/Dovobet gel including 21-days cumulative irritation study and sensitisation potential in 200 healthy subjects

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2006

MBL 0301 UK

Assessment of the photosensitisation potential of Daivobet/Dovobet gel containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)

N/A

2005-001226-91

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2006

OA 0401 CA

A bioavailability study to assess the bioequivalence of alfacalcidol capsule and oral drop formulations: A comparative, randomized, single-dose, 4-way crossover bioavailability study of LEO Pharma A/S alfacalcidol (One-Alpha®) capsules and oral drops following a dose of 10 µg in healthy adult volunteers under fasting conditions

N/A

N/A

Summary

Report

Active Substance

alfacalcidol

LEO Pharma Product

One-Alpha®

Formulation

capsule & oral drops

Trial Phase

1

Population

adults

2005

MBL 0303 FR

Phototoxicity study: Assessment of the phototoxic potential of Daivobet/Dovobet (calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) gel

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

gel

Trial Phase

1

Population

adults

2005

OA 0403 CA

A bioavailability study to investigate food interaction with a single dose of alfacalcidol: A comparative, randomized, single-dose, 3-way crossover, food effect and absolute bioavailability study of LEO Pharma alfacalcidol (One-Alpha®) following a dose of 10 μg in healthy adult volunteers

N/A

N/A

Summary

Report

Active Substance

alfacalcidol

LEO Pharma Product

One-Alpha®

Formulation

capsule & injectional solution

Trial Phase

1

Population

adults

2004

MCB 0306 UK

Daivobet/Dovobet ointment / UV penetration study in humans - detection of erythema induced by UV light, a within subject comparison of investigational materials against untreated skin

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. &calcipotriol

LEO Pharma Product

Daivobet® & Daivonex®/ Dovonex®

Formulation

ointment & scalp solution

Trial Phase

1

Population

adults

2003

MCB 0202 FR

Repeat insult patch test with Daivobet / Dovobet ointment - a study on the sensitisation potential of Daivobet / Dovobet ointment and the ointment vehicle when applied on healthy skin in 200 healthy subjects

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2003

MCB 0204 FR

Photo-allergy test: Assessment of the photosensitisation potential of Daivobet/Dovobet ointment (calcipotriol 50 µg/g and betamethasone (as dipropionate) 0.5 mg/g)

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2003

MCB 0203 FR

21-day cumulative irritation test: Assessment of the local skin tolerability, after repeated application of Daivobet/Dovobet ointment (calcipotriol 50 µg/g and betamethasone (as dipropionate) 0.5 mg/g)

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2002

MCB 0101 FR

Photo-toxicity study: Assessment of the phototoxic potential of Daivobet®/Dovobet® ointment (betamethasone dipropionate 0.5mg/g and calcipotriol 50μg/g)

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2001

MCO 9407 CA

Atrophogenic potential of calcipotriol, betamethasone and mometasone

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

1

Population

adults

2000

IN 9801 FR

An open (uncontrolled) clinical phase I study to assess the pharmacokinetic profile of tinzaparin (innohep®, LEO) after multiple subcutaneous doses in healthy male volunteers

N/A

N/A

Summary

Report

Active Substance

tinzaparin

LEO Pharma Product

innohep®

Formulation

injectional solution

Trial Phase

1

Population

adults

1999

MET 9802 FR

A comparative single dose bioavailability study of mecillinam in eighteen healthy male volunteers following oral administration of a new 400 mg pivmecillinam tablet versus oral administration of two 200 mg pivmecillinam tablets.

N/A

N/A

Summary

Report

Active Substance

pivmecillinam