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 AUC0-t, AUC0-∞;, 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 AUC0-t, AUC0-∞, and Cmax 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.
|Number of pages||5|
|Journal||International Journal of Clinical Pharmacology and Therapeutics|
|Publication status||Published - 1 Mar 2016|
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