Status:

COMPLETED

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

Lead Sponsor:

Pierre Fabre Dermatology

Conditions:

Healthy Volunteers

Eligibility:

MALE

18-50 years

Phase:

PHASE1

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 prod...

Eligibility Criteria

Inclusion

  • Healthy male subject aged 18 to 50 years (inclusive)

Exclusion

  • 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

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2013

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT01861626

Start Date

May 1 2013

End Date

June 1 2013

Last Update

June 19 2013

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Erfurt, Germany, D-99084