Wen Yao Mak
Clinical Research Centre,
Jalan Tun Hussein Onn, 13700 Perai, Pulau Pinang
Malaysia
Research Article
Pharmacokinetic Comparison and Bioequivalence Study of Two Rosuvastatin 20 mg Formulations in Healthy Volunteers
Author(s): Wen Yao Mak, Siew Siew Tan, Jia Woei Wong, Siaw Kuen Chin, Ai Boey Lim, Ean Peng Soon, Irene Looi and Kah Hay YuenWen Yao Mak, Siew Siew Tan, Jia Woei Wong, Siaw Kuen Chin, Ai Boey Lim, Ean Peng Soon, Irene Looi and Kah Hay Yuen
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. .. View More»
DOI:
10.4172/jbb.1000275