Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pierre Fabre Dermatology
• Treatments: Isotretinoin

Criteria

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