Bioequivalence of rosuvastatin calcium tablets in Chinese healthy subjects

Author: Ying CAO ¹ ; Wenping WANG ¹ ; Xiaobin LI ¹ ; Huawei WANG ¹ ; Xin SUI ¹ ; Ming YU ¹ ; Lu CHEN ¹ ; Xiaoyan DOU ¹ ; Xiujun WU ¹ ; Ran MA ¹ ; Meiye LI ¹ ; Xue GAO ¹
Author Information

1. Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, GCP Center Phase I Clinical Trial Ward
Publication Type:Journal Article
Keywords: Bioequivalence; Healthy subjects; LC-MS/MS; Rosuvastatin calcium tablets
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2020;25(12):1369-1375
CountryChina
Language:Chinese
Abstract: AIM: To study the bioequivalence of rosuvastatin calcium tablets produced by two different manufacturers on a fasting and postprandial basis in Chinese healthy subjects. METHODS: A single-center, randomized, balanced, open, two-sequence, two-cycle, double-crossover, and single-dose trial design was used in this study. Each of the fasting group and the postprandial group was enrolled in 52 healthy subjects. Fasting/postprandial oral rosuvastatin calcium tablets 10 mg test preparation or reference preparation, the validated LC-MS/MS method was used to determine the concentration of rosuvastatin calcium tablets in plasma, and the pharmacokinetic parameters were calculated. Human bioequivalence and safety evaluation of two rosuvastatin calcium tablets were evaluated. RESULTS: The t