Trials in healthy subjects

Report Year
Trial Code
Trial Title
Clinicaltrials.gov
EudraCTno.
Source
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
N/A
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
2015-005073-20
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
2014-003337-25
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
N/A
 
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
2014-001450-42
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
2013-004346-41
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
2014-003677
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
2012-004264-21
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
2012-002660-28
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
N/A
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)
2014-003677
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)
N/A
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
2009-017394-38
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
N/A
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
N/A
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
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
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
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
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
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
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
N/A
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Active Substance
bumetanide
LEO Pharma Product
Burinex®
Formulation
tablet
Trial Phase
1
Population
adults

 

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