Overview

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

Status:
Completed
Trial end date:
2013-07-15
Target enrollment:
Participant gender:
Summary
This is an open-label, crossover, randomized, single dose, three treatments, three periods and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin. Bioequivalence will be compared between the reference medication one (T1) vs the test medication (T3): (T1 vs T3); and the reference medication two (T2), vs test medication (T3): (T2 vs T3). Finally, treatments T1 vs T2 will be compared statistically to determine if they are bioequivalent.
Phase:
Phase 1
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Isotretinoin