[Translation] A single-dose, postprandial, randomized, open-label, two-formulation, two-period, two-crossover bioequivalence study of spironolactone oral suspension in healthy subjects
主要研究目的:本研究以成都倍特得诺药业有限公司生产的螺内酯口服混悬液(118ml:0.59g)为受试制剂,以Cmp Development Llc持有的螺内酯口服混悬液(118ml:0.59g(25mg/5mL,118mL/瓶),商品名:CAROSPIR®)为参比制剂,评价受试制剂和参比制剂在餐后条件下给药的生物等效性。次要研究目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary study objective: This study used spironolactone oral suspension (118ml: 0.59g) produced by Chengdu Beitedenuo Pharmaceutical Co., Ltd. as the test preparation and spironolactone oral suspension (118ml: 0.59g (25mg/5mL, 118mL/bottle), trade name: CAROSPIR®) held by Cmp Development Llc as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under postprandial conditions. Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.