Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects
Status and phase
Completed
Phase 1
Conditions
Healthy Volunteers
Treatments
Drug: V0057 - A mg
Drug: Isotretinoin
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
45 patients
Sex
Male
Ages
18 to 50 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
45 participants in 2 patient groups
sequence 1 : Test drug - Reference
Other group
Treatment:
Drug: V0057 - A mg
Drug: Isotretinoin
Sequence 2 : Reference - Test drug
Other group
Treatment:
Drug: V0057 - A mg
Drug: Isotretinoin
Trial contacts and locations
1
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems