[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of potassium chloride sustained-release tablets (8 mEq) in healthy Chinese subjects under fasting conditions
主要研究目的: 按有关生物等效性试验的规定,选择 UPSHER-SMITH LABORATORIES, LLC 为持证商的氯化钾缓释片(商品名:KLOR-CON®,规格:8mEq)为参比制剂,对澳美制药(海南)有限公司生产并提供的受试制剂氯化钾缓释片(规格:8mEq)进行空腹给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂氯化钾缓释片(规格:8mEq)和参比制剂氯化钾缓释片(商品名:KLOR-CON®,规格:8mEq)的安全性。
[Translation] Main purpose of study: According to the relevant provisions of bioequivalence test, potassium chloride sustained-release tablets (trade name: KLOR-CON®, specification: 8mEq) of UPSHER-SMITH LABORATORIES, LLC as the licensee were selected as the reference preparation, and the test preparation potassium chloride sustained-release tablets (specification: 8mEq) produced and provided by Aome Pharmaceutical (Hainan) Co., Ltd. were subjected to fasting human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions.
Secondary purpose of study: To observe the safety of oral administration of the test preparation potassium chloride sustained-release tablets (specification: 8mEq) and the reference preparation potassium chloride sustained-release tablets (trade name: KLOR-CON®, specification: 8mEq) by healthy volunteers.