Zhejiang Hemukang Pharmaceutical Technology Co., Ltd.

The relative bioavailability of a single oral dose of the test preparation valsartan levoamlodipine tablets (specification: 80 mg/2.5 mg) and the reference preparations valsartan tablets (DIOVAN®, specification: 80 mg) and amlodipine besylate tablets (Norvasc®, specification: 5 mg) in healthy Chinese subjects under fasting conditions was studied, the pharmacokinetic parameters of the two preparations were analyzed, and the bioequivalence of the two preparations taken orally under fasting conditions was evaluated, so as to provide a reference for the application and clinical use of the drug.

To evaluate the effectiveness of valsartan-amlodipine tablets (specification: 80mg/2.5mg) in the treatment of mild to moderate essential hypertension by 24-hour ambulatory blood pressure monitoring (ABPM); To evaluate the safety of valsartan-amlodipine tablets (specification: 80mg/2.5mg) in the treatment of mild to moderate essential hypertension by 24-hour ambulatory blood pressure monitoring (ABPM).

Main study objectives To study the pharmacokinetics of the test preparation sulindac tablets (specification: 200mg, produced by Chengdu Tongde Pharmaceutical Co., Ltd., provided by Zhejiang Hemukang Pharmaceutical Technology Co., Ltd.) and the reference preparation sulindac tablets (Sulindac®, specification: 200mg; produced by Watson Pharma Private Ltd., licensed by WATSON LABORATORIES INC) in humans 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 study objectives To evaluate the safety of the test preparation sulindac tablets and the reference preparation sulindac tablets (Sulindac®) after a single oral administration in fasting and fed state in healthy Chinese subjects.