Skin Infections (Acne) Clinical Trial
Official title:
Bioequivalence Study for an Isotretinoin Pharmaceutical Preparation - Capsules. Crossover, Randomized, Single Dose, Two Treatments, Two Periods and Two Sequences With Meal (Breakfast) Study
The objective of this study was to confirm if two formulations of isotretionin (capsules) are
bioequivalent.
Test product was Oratane® 20 mg (Laboratorios Dermatológicos Darier) and reference product
Roaccutan® 20 mg (Productos Roche). Two capsules administered together were the single
dosage.
The study was prospective, open-label, randomized, crossover, single dose, with 02
treatments, 02 sequences and 02 periods, under fed conditions.
The population was composed of 36 healthy volunteers, male adults between 18-45 years.
The comparative bioavailability of the two formulations was evaluated based in statistical
comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
in blood.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01755611 -
Bioequivalence Minocycline Bioequivalence
|
Phase 1 |