Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects.

AIM To compare the bioavailability of two 40-mg Rosuvastatin tablet formulations. METHODS 24 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 2-week wash out period was applied. Blood samples were drawn up to 72 hours following drug administrations. Rosuvastatin plasma concentrations were determined by liquid chromatography-tandem mass spectrometry method with TurboIon-Spray mode. Pharmacokinetic parameters AUC(0-t), AUC(0-∞), and Cmax were determined and used for bioequivalence evaluation after log-transformation, whereas tmax ratios were evaluated nonparametrically. RESULTS The estimated point and 90% confidence intervals (CI) for AUC(0-t), AUC(0-∞), and C(max) for rosuvastatin were 95.21% (87.56 - 103.53%), 95.76% (88.01 - 104.18%), and 99.33% (89.37 - 110.41%), respectively. CONCLUSION These results indicated that the two formulations of rosuvastatin were bioequivalent; therefore, they may be prescribed interchangeably.