[Translation] A randomized, open-label, postprandial, single-dose, two-cycle, double-crossover bioequivalence trial of tinidazole tablets (500 mg) in healthy Chinese subjects
主要研究目的:本研究以,湖北广济药业股份有限公司生产的替硝唑片(规格0.5g),Mission Pharmacal Company生产,Mikart inc Atlanta GA持证的替硝唑片(商品名:TINDAMAX®,规格:500mg/片)为参比制剂,评估受试制剂和参比制剂在餐后条件下给药时的生物等效性。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] Main research purpose: In this study, tinidazole tablets (specification 0.5g) produced by Hubei Guangji Pharmaceutical Co., Ltd., produced by Mission Pharmacal Company, and licensed by Mikart inc Atlanta GA (trade name: TINDAMAX® , specification: 500mg/tablet) is the reference preparation, and the bioequivalence of the test preparation and the reference preparation when administered under postprandial conditions is evaluated. Secondary research objectives: To observe the safety of test and reference products in healthy subjects.