Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects

• Published in: International journal of clinical pharmacology and therapeutics Vol. 54; no. 3; pp. 212 - 216
• Main Authors: Harahap, Yahdiana, Prasaja, Budi, Azmi, Fahmi, Lusthom, Windy, Sinandang, Theresia, Felicia, Vita, Yusvita, Lia Yumi, Panjaitan, Lianna Y.
• Format: Journal Article
• Language: English
• Published: Germany Dustri - Verlag Dr. Karl Feistle GmbH & Co. KG 01.03.2016
• Subjects: Acids; Area Under Curve; Bioavailability; Bioequivalence; Calories; Chemistry, Pharmaceutical; Cholesterol; Cross-Over Studies; Drug dosages; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacokinetics; Laboratories; Male; Medical research; Pharmaceuticals; Pharmacokinetics; Pharmacy; Plasma; Rosuvastatin Calcium - pharmacokinetics; Statins; Tablets; Therapeutic Equivalency
• ISSN: 0946-1965
• DOI: 10.5414/CP202345

To compare the bioavailability of two 40-mg Rosuvastatin tablet formulations. 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. 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. These results indicated that the two formulations of rosuvastatin were bioequivalent; therefore, they may be prescribed interchangeably.