[Translation] Single center, randomized, open, single (fasting/fed) oral administration, two preparations, two sequences, two cycles, crossover human bioequivalence test of hydrochlorothiazide tablets in Chinese healthy subjects.
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂氢氯噻嗪片(规格:25mg;生产企业:云鹏医药集团有限公司)和参比制剂氢氯噻嗪片(商品名:Esidrix®;规格:25mg;持证商:Laboratoires Juvise Pharmaceuticals)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂氢氯噻嗪片和参比制剂氢氯噻嗪片(Esidrix®)在中国健康受试者中的安全性。
[Translation] Main purpose: To observe Chinese healthy subjects taking a single oral administration of the test preparation Hydrochlorothiazide Tablets (specification: 25mg; manufacturer: Yunpeng Pharmaceutical Group Co., Ltd.) and the reference preparation Hydrochlorothiazide Tablets (trade name: Esidrix ®; Specification: 25mg; Licensee: Laboratoires Juvise Pharmaceuticals) to evaluate the bioequivalence of the two preparations in the fasting/fed state.
Secondary objective: To observe the safety of the test preparation Hydrochlorothiazide Tablets and the reference preparation Hydrochlorothiazide Tablets (Esidrix®) in Chinese healthy subjects.