[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover bioequivalence study of fasting and fed oral levamlodipine besylate tablets in healthy Chinese volunteers
本试验旨在研究单次空腹和餐后口服安徽省先锋制药有限公司研制、生产的苯磺酸左氨氯地平片(5 mg)的药代动力学特征;以辉瑞制药有限公司生产的苯磺酸氨氯地平片(络活喜®,10 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-72,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of levamlodipine besylate tablets (5 mg) developed and produced by Anhui Pioneer Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using amlodipine besylate tablets (Norvasc®, 10 mg) produced by Pfizer Pharmaceuticals Co., Ltd. as the reference preparation, the pharmacokinetic parameters Cmax and AUC0-72 of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.