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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861626
• Other study ID #: V00057 CA 1 01
• Secondary ID: 2013-000988-80
• Status: Completed
• Phase: Phase 1
• First received: May 15, 2013
• Last updated: June 18, 2013
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Pierre Fabre Dermatology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• V0057 - A mg
Single oral administration
• Isotretinoin
Single oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Dermatology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)		18 time points up to 72h after administration	No
Primary	Time of Maximum Concentration (Tmax)		18 time points up to 72h after administration	No
Primary	Area under curve (AUC0-72)		18 time points up to 72h after administration	No