Research Article
Wen Yao Mak, Siew Siew Tan,
Abstract
The present study investigated the pharmacokinetics and bioequivalence between two oral rosuvastatin formulations. The study was designed as a two-way crossover, two-period, open-label, randomised, single-dose investigation. Washout period was determined as 14 days due to the long elimination half-life of rosuvastatin. Bioanalysis of plasma samples was performed via liquid chromatography tandem mass spectrometry. The pharmacokinetic parameters were analysed with the non-compartmental model. The study showed AUC0-t, AUC0-∞, and Cmax were within the limit of 80.00%-125.00%, and concluded the two products were bioequivalent and interchangeable.