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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Erfurt, D-99084, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V0057 - A mg

Drug

Single oral administration

isotretinoin

Drug

Single oral administration

Primary outcomes

Maximum Plasma Concentration (Cmax)

Time frame: 18 time points up to 72h after administration
Time of Maximum Concentration (Tmax)

Time frame: 18 time points up to 72h after administration
Area under curve (AUC0-72)

Time frame: 18 time points up to 72h after administration

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermatology

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: May 23, 2013
Registry last updated: Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed