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

NCT01861626 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2013-06-19

No results posted yet for this study

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

  • Healthy Volunteers

Interventions

DRUG

V0057 - A mg

Single oral administration

DRUG

Isotretinoin

Single oral administration

Sponsors & Collaborators

  • Pierre Fabre Dermatology

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01861626 on ClinicalTrials.gov