[Translation] Randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of potassium citrate sustained-release tablets (15mEq) under fasting and fed administration conditions in Chinese healthy subjects
主要研究目的:按有关生物等效性试验的规定,选择MISSION PHARMA为持证商的枸橼酸钾缓释片(商品名:Urocit-K,规格:15mEq)为参比制剂,对成都硕德药业有限公司生产的受试制剂枸橼酸钾缓释片(规格:15mEq)进行空腹和餐后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,比较两种制剂在空腹和餐后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枸橼酸钾缓释片(规格:15mEq)和参比制剂枸橼酸钾缓释片(商品名:Urocit-K,规格:15mEq)的安全性。
[Translation] The main purpose of the study: According to the relevant bioequivalence test regulations, select potassium citrate sustained-release tablets (trade name: Urocit-K, specification: 15mEq) with MISSION PHARMA as the licensed manufacturer as the reference preparation, and to test the effect on Chengdu Shuode The test preparation Potassium Citrate Sustained-release Tablets (specification: 15mEq) produced by Pharmaceutical Co., Ltd. was administered to humans on an empty stomach and after meals for bioequivalence tests, and the absorption rate and degree of drug absorption in the test preparation were compared with those of the reference Whether the difference of the preparation is within the acceptable range, compare the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the oral administration of the test preparation potassium citrate sustained-release tablets (specification: 15mEq) and the reference preparation potassium citrate sustained-release tablets (trade name: Urocit-K, specification: 15mEq) in healthy volunteers security.