Trials / Completed
CompletedNCT01861626
Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Pierre Fabre Dermatology · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | V0057 - A mg | Single oral administration |
| DRUG | Isotretinoin | Single oral administration |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2013-05-23
- Last updated
- 2013-06-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01861626. Inclusion in this directory is not an endorsement.