International Bio Service Co., Ltd., 888 Golden Jubilee Medical Center, Mahidol University, Nakhon Pathom 73170, Thailand
Research Article
Bioequivalence Study of Rosuvastatin 20 mg Tablets in Healthy Thai Volunteers under Fasting Conditions
Author(s): Jaturavit Vattanarongkup, Charinthon Seeduang, Sumate Kunsa-ngiem, Vipada Khaowroongrueng*, Lalinthip Saeaue, Busarat Karachot, Piengthong Narakorn, Porranee Puranajoti and Isariya Techatanawat
Rosuvastatin is a member of high-potency statins. It is indicated for the treatment of homozygous familial
hypercholesterolemia, hyperlipidemia, mixed dyslipidemia, primary dysbetalipoproteinemia, and hypertriglyceridemia.
The study aimed to compare the rate and extent of absorption as well as safety of two rosuvastatin 20 mg tablet
formulations; the test product ROZACOR® manufactured by the Government Pharmaceutical Organization,
Thailand and the reference product CRESTOR® manufactured by IPR Pharmaceuticals Inc., Puerto Rico. An
open label, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover bioequivalence study
was conducted in healthy Thai adult volunteers under fasting conditions. The concentrations of rosuvastatin in
plasma samples were determined using a validated liquid chromatography-tandem mass .. View more»