Yuanhe Pharmaceutical Group Lndustry Co., Ltd.

The pharmacokinetics of the test preparation irbesartan hydrochlorothiazide capsules (Anlibo, specifications: 150 mg/12.5 mg/capsule, produced by Yuanhe Pharmaceutical Co., Ltd.) and the reference preparation irbesartan hydrochlorothiazide tablets (Anbono®, specifications: 150 mg/12.5 mg/tablet; produced by Sanofi Clir SNC) were studied in healthy subjects after a single oral administration under fasting and fed conditions, and the bioequivalence of the two preparations in fasting and fed conditions, as well as their safety in healthy subjects were evaluated.

Primary objective: To verify that Verapamil Hydrochloride Delayed-Release Tablets are superior to placebo in reducing morning diastolic blood pressure (ambulatory blood pressure) after 8 weeks of treatment: To evaluate the safety of Verapamil Hydrochloride Delayed-Release Tablets in hypertensive subjects after 8 weeks of treatment. Secondary objectives: Verapamil Hydrochloride Delayed-Release Tablets are superior to placebo in reducing office blood pressure after 4 and 8 weeks of treatment; The proportion of subjects who need to increase the amount of Verapamil Hydrochloride Delayed-Release Tablets after 4 weeks of treatment.

The pharmacokinetics of the test preparation irbesartan hydrochlorothiazide capsules (Anlibo, specifications: 150 mg/12.5 mg/capsule, produced by Yuanhe Pharmaceutical Co., Ltd.) and the reference preparation irbesartan hydrochlorothiazide tablets (Anbono®, specifications: 150 mg/12.5 mg/tablet; produced by Sanofi Clir SNC) in healthy subjects after a single oral administration in the fed state were studied, and the bioequivalence of the two oral preparations in the fed state and their safety in healthy subjects were evaluated.