[Translation] Randomized, open-label, single-dose, two-dose, three-period, three-sequence bioequivalence study of losartan potassium and hydrochlorothiazide tablets in healthy subjects under fasting and high-fat fed states
主要目的:以山东信谊制药有限公司研制的氯沙坦钾氢氯噻嗪片(每片含氯沙坦钾50mg和氢氯噻嗪12.5mg)为受试制剂,以Merck Sharp & Dohme Limited (U.K.)生产的氯沙坦钾氢氯噻嗪片(每片含氯沙坦钾50mg和氢氯噻嗪12.5mg,商品名:海捷亚)为参比制剂,按生物等效性试验的相关规定,评价两种制剂的生物等效性。
次要目的:评价中国健康受试者单次空腹/高脂餐后口服氯沙坦钾氢氯噻嗪片受试制剂和参比制剂后的安全性。
[Translation] Main purpose: Take losartan potassium and hydrochlorothiazide tablets (each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide) developed by Shandong Xinyi Pharmaceutical Co., Ltd. Tan Potassium Hydrochlorothiazide Tablets (each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide, trade name: Hyzaia) is the reference preparation, and the bioequivalence of the two preparations is evaluated according to the relevant provisions of the bioequivalence test.
Secondary objective: To evaluate the safety of Chinese healthy subjects after a single fasting/high-fat meal orally taking the test formulation and reference formulation of Losartan Potassium Hydrochlorothiazide Tablets.