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CompletedNCT01861626Updated Jun 19, 2013

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

A Phase 1 interventional study of V0057 - A mg and Isotretinoin in Healthy Volunteers, sponsored by Pierre Fabre Dermatology. Completed at 1 site in Germany. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-19.

Sponsored by Pierre Fabre Dermatology · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Pierre Fabre Dermatology is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Other
    sequence 1 : Test drug - Reference

    Drug: V0057 - A mg · Drug: Isotretinoin

  • Other
    Sequence 2 : Reference - Test drug

    Drug: V0057 - A mg · Drug: Isotretinoin

Interventions

  • DrugV0057 - A mg

    Single oral administration

  • DrugIsotretinoin

    Single oral administration

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

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

  2. Time of Maximum Concentration (Tmax)

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

  3. Area under curve (AUC0-72)

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

07

Study locations

1 site
  • Erfurt, D-99084, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01861626
Lead sponsor
Pierre Fabre Dermatology
Responsible party
Sponsor
First posted
May 23, 2013
Start date
May 2013
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Jun 19, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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