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

Information source: Pierre Fabre Dermatology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: V0057 - A mg (Drug); Isotretinoin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pierre Fabre Dermatology

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum Plasma Concentration (Cmax)

Time of Maximum Concentration (Tmax)

Area under curve (AUC0-72)

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

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

Locations and Contacts

Erfurt D-99084, Germany
Additional Information

Starting date: May 2013
Last updated: June 18, 2013

Page last updated: August 23, 2015

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