Abstract
This study aimed to evaluate the bioequivalence between two products containing Clozapine 100 mg (testing product: LifalClozapina® from Lifal – Industrial Pharmaceutical Laboratory of Alagoas S/A and the reference product: Leponex® from the Novartis Biociencias S/A. Laboratories) in 40 volunteers. The study was open, randomized, cross-over type, in a state of equilibrium, with two periods (two sequences) in which volunteers were given, in each period, the testing formulation or the reference formulation. The relative bioavailability of the formulations following oral administration was evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from blood samples in a 24 hours period. The concentration of Clozapine was measured using an appropriate and valid analytical method. The pharmacokinetic measures used were: Cmin and Cmax, and ASCt. The mean differences (± SD) between reference and testing were: 0.1615 ± 0.3404 (ng/mL); -0.0969 ± 0.4131 (ng/mL); and 0.9143 ± 3.9941 (ng*h/mL). The confidence intervals for medium bioequivalence met the limits determined by the National Agency of Sanitary Surveillance (ANVISA) of 80 to 125%, and both medications were considered bioequivalent. Thus, the testing and reference products are considered interchangeable.
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