Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects
- Registration Number
- NCT01861626
- Lead Sponsor
- Pierre Fabre Dermatology
- Brief Summary
The purpose of this study is to evaluate the bioequivalence (comparison of the rate and extent of the active substance into the body following single administration of the drugs) between the test product V0057 and a reference product after two single oral administration separate by 7 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 45
Inclusion Criteria
- Healthy male subject aged 18 to 50 years (inclusive)
Exclusion Criteria
- Presence of any significant medical finding or significant history that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
- Presence of any clinically significant abnormal finding at examination in the Investigator's opinion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 2 : Reference - Test drug Isotretinoin - Sequence 2 : Reference - Test drug V0057 - A mg - sequence 1 : Test drug - Reference V0057 - A mg - sequence 1 : Test drug - Reference Isotretinoin -
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) 18 time points up to 72h after administration Time of Maximum Concentration (Tmax) 18 time points up to 72h after administration Area under curve (AUC0-72) 18 time points up to 72h after administration
- Secondary Outcome Measures
Name Time Method