Bioequivalence Study of V0057 Versus a Reference Formulat... | NCT01861626

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

NCT01861626

Sponsor

Pierre Fabre Dermatology

Status

Completed

Last Update Posted

Jun 19, 2013Estimated

Enrollment

45Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

V0057 - A mg
Isotretinoin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-000988-80	EudraCT Number

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

May 15, 2013

First Submission Date that Met QC Criteria

May 21, 2013

First Posted Date

May 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2013

Last Update Posted Date

Jun 19, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sequence 1 : Test drug - Reference	Other		Drug: V0057 - A mg Drug: Isotretinoin
Sequence 2 : Reference - Test drug	Other		Drug: V0057 - A mg Drug: Isotretinoin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
V0057 - A mg	Drug	Single oral administration	Sequence 2 : Reference - Test drug sequence 1 : Test drug - Reference

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015474	Isotretinoin

Ancestor Terms

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839

Browse Leaves

Not provided

Browse Branches

Not provided