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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01861626

Enrollment

Registered

2013-05-23

Start date

2013-05-31

Completion date

2013-06-30

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGV0057 - A mg

Single oral administration

DRUGIsotretinoin

Single oral administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026