Shenzhen Osa Pharmaceutical Co., Ltd.

1. Main purpose Comparison of amlodipine folic acid tablets (B Is there any significant difference in the efficacy of preventing first ischemic stroke between Group A) and amlodipine tablets (Group A)? 2. Secondary purpose (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing first ischemic stroke between group B and group A in the CC and CT genotype groups. (2) Among the above-mentioned hypertensive participants, compare the efficacy of group B and group A in preventing first stroke, cardiovascular and cerebrovascular composite endpoints, and renal endpoints in the CC or CT genotype population, and the CC and CT genotype population respectively. The difference. (3) Among the above-mentioned hypertensive participants, compare whether there are significant differences in the efficacy of preventing first hemorrhagic stroke, first myocardial infarction, first coronary revascularization, and cardiovascular and cerebrovascular death between group B and group A. 3. Other purposes (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing malignant tumors and all-cause death between group B and group A. (2) Among the above-mentioned hypertensive participants, compare the preventive blood pressure levels, variability, blood pressure target compliance rate, serum folate levels and changes between group B and group A respectively in the CC or CT genotype population, CC and CT genotype population, Are there significant differences in therapeutic efficacy in plasma total homocysteine levels and changes.

1. Main research purpose Among hypertensive participants with MTHFR 677 TT genotype, compare whether there is a significant difference in the efficacy of amlodipine folic acid tablets (group B+C) and amlodipine tablets (group A) in preventing first ischemic stroke. 2. Secondary research purpose (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing first ischemic stroke between group B vs. group A, group C vs. group A, and group B vs. group C. (2) Among the above-mentioned hypertensive participants, compare group B+C vs. group A, group B vs. group A, group C vs. group A, group B vs. group C in preventing first stroke and cardiovascular and cerebrovascular composite endpoints. , whether there is a significant difference in the efficacy of renal endpoints. (3) In the above-mentioned hypertensive participants, compare group B+C vs. group A in preventing first hemorrhagic stroke. Is there a significant difference in the efficacy of first myocardial infarction, first coronary revascularization, and cardiovascular and cerebrovascular death? 3. Other research purposes (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing malignant tumors and all-cause death between group B+C and group A. (2) Among the above-mentioned hypertensive participants, compare the preventive blood pressure levels, variability and blood pressure reduction standards of group B+C vs. group A, group B vs. group A, group C vs. group A, group B vs. group C. rate, serum folate levels and changes, and plasma total homocysteine levels and changes.

Primary objective: To evaluate the bioequivalence of a single oral dose of the test formulation (valsartan hydrochlorothiazide tablets, Shenzhen Osa Pharmaceutical Co., Ltd., specifications: each tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide) and a reference formulation (CoDiovan®, Novartis Pharma Schweiz AG, specifications: each tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide) in healthy subjects on an empty stomach and after a meal. Secondary objective: To observe the safety of the test formulation and the reference formulation when taken orally on an empty stomach and after a meal.