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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sequence 1 : Test drug - Reference

Group Type OTHER

V0057 - A mg

Intervention Type DRUG

Single oral administration

Isotretinoin

Intervention Type DRUG

Single oral administration

Sequence 2 : Reference - Test drug

Group Type OTHER

V0057 - A mg

Intervention Type DRUG

Single oral administration

Isotretinoin

Intervention Type DRUG

Single oral administration

Interventions

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V0057 - A mg

Single oral administration

Intervention Type DRUG

Isotretinoin

Single oral administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes