Shandong Sine Pharmaceutical Co., Ltd.

Main objective: To compare the absorption rate and extent of Nicorandil tablets provided by Shandong Xinyi Pharmaceutical Co., Ltd. with those of Nicorandil tablets certified by Chugai Pharmaceutical Co., Ltd. in healthy human bodies according to the relevant provisions of bioequivalence studies, and to investigate the bioequivalence of the two preparations in humans.

Nicorandil tablets produced by Shandong Xinyi Pharmaceutical Co., Ltd. were used as the test preparation, and Nicorandil tablets produced by Chugai Pharmaceutical Co., Ltd. were used as the reference preparation to conduct human pharmacokinetic studies to confirm the scientificity and rationality of the experimental plan.

Primary objective: To evaluate the bioequivalence of the two preparations according to the relevant provisions of bioequivalence tests, using losartan potassium hydrochlorothiazide tablets (each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide) developed by Shandong Xinyi Pharmaceutical Co., Ltd. as the test preparation and losartan potassium hydrochlorothiazide tablets (each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide, trade name: Hyzaar) produced by Merck Sharp & Dohme Limited (U.K.) as the reference preparation. Secondary objective: To evaluate the safety of the test preparation and reference preparation of losartan potassium hydrochlorothiazide tablets after a single oral administration on an empty stomach or after a high-fat meal in healthy Chinese subjects.