[Translation] Single-center, randomized, open-label, single-dose, two-preparation, two-cycle, two-sequence crossover design, fasting dosing human bioequivalence study
本试验旨在研究单次空腹口服华润双鹤利民药业(济南)有限公司研制、生产的波生坦分散片(32 mg)的药代动力学特征;以Actelion Pharmaceuticals Ltd持证、Patheon Inc.生产的波生坦分散片(Tracleer®,32 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This trial aims to study the pharmacokinetic characteristics of bosentan dispersible tablets (32 mg) developed and produced by China Resources Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd. after a single fasting oral administration; licensed by Actelion Pharmaceuticals Ltd, Patheon Inc .The produced bosentan dispersible tablets (Tracleer®, 32 mg) are used as reference preparations. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations are compared to evaluate the human bioequivalence of the two preparations.