NCT01861626

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 product V0057 and a reference product after two single oral administration separate by 7 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2013

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1 month

First QC Date

May 15, 2013

Last Update Submit

June 18, 2013

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • Maximum Plasma Concentration (Cmax)

    18 time points up to 72h after administration

  • Time of Maximum Concentration (Tmax)

    18 time points up to 72h after administration

  • Area under curve (AUC0-72)

    18 time points up to 72h after administration

Study Arms (2)

sequence 1 : Test drug - Reference

OTHER
Drug: V0057 - A mgDrug: Isotretinoin

Sequence 2 : Reference - Test drug

OTHER
Drug: V0057 - A mgDrug: Isotretinoin

Interventions

V0057 - A mgDRUG

Single oral administration

Sequence 2 : Reference - Test drugsequence 1 : Test drug - Reference
IsotretinoinDRUG

Single oral administration

Sequence 2 : Reference - Test drugsequence 1 : Test drug - Reference

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Erfurt, D-99084, Germany

Location

MeSH Terms

Interventions

Isotretinoin

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 23, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

DE(1)