A Study to Determine Bioequivalence of Isotretinoin in Healthy Male Subjects Under Fed Condition

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

July 15, 2013

Study Completion Date

July 15, 2013

Conditions
Acne Vulgaris
Interventions
DRUG

Isotretinoin: Reference Medication 1

Isotretinoin reference medication 1 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each)

DRUG

Isotretinoin: Reference Medication 2

Isotretinoin reference medication 2 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each)

DRUG

Isotretinoin: Test Medication

Isotretinoin test medication will contain isotretinoin 40 mg (2 capsules of 20 mg each) in the same type of pharmaceutical presentation, containing the same drug but possible to have a different excipients.

Trial Locations (1)

64600

GSK Investigational Site, Monterrey

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY