Zhejiang Kinglyuan Pharmaceutical Co. Ltd.

The main purpose of the study is to test the pharmacokinetics of the test preparation valsartan hydrochlorothiazide tablets (specification: 80/12.5mg (each tablet contains 80mg valsartan and 12.5mg hydrochlorothiazide), Zhejiang Jinliyuan Pharmaceutical Co., Ltd.) and the reference preparation valsartan hydrochlorothiazide tablets (Co-Diovan®, specification: 80/12.5mg (each tablet contains 80mg valsartan and 12.5mg hydrochlorothiazide), produced by Novartis Farma S.p.A. (I)) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary purpose of the study: to evaluate the safety of the test preparation and reference preparation of valsartan hydrochlorothiazide tablets in healthy subjects after a single oral administration in the fasting and fed state.

Telmisartan tablets provided by Zhejiang Jinliyuan Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of bioequivalence study, the absorption rate and degree of Telmisartan tablets (trade name: Micardis®, reference preparation) produced by Boehringer Ingelheim Ellas A.E. (licensed manufacturer: Boehringer Ingelheim International GmbH) were compared in healthy humans to investigate the bioequivalence of the two preparations in humans.

Primary objective: To investigate the pharmacokinetic parameters and relative bioavailability of Telmisartan Tablets (test preparation; specification: 80 mg) developed by Zhejiang Jinliyuan Pharmaceutical Co., Ltd. and Telmisartan Tablets (reference preparation; specification: 80 mg; English trade name: MICARDIS ®; Chinese trade name: 美卡素®) produced by Boehringer Ingelheim Pharma GmbH & Co. KG, and to evaluate whether the two are bioequivalent in the postprandial administration state of healthy subjects. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.