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.