[Translation] Ornidazole Capsules (0.25g) in Chinese healthy subjects under fasting and postprandial conditions, single-center, randomized, open, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial
主要研究目的:按有关生物等效性试验的规定,选择OrPha Swiss GmbH为持证商的奥硝唑片(商品名:Tiberal®,规格:0.5g)为参比制剂,对西安万隆制药股份有限公司生产的受试制剂奥硝唑胶囊(规格:0.25g)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,评价两种制剂在空腹及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奥硝唑胶囊(规格:0.25g)和参比制剂奥硝唑片(商品名:Tiberal®,规格:0.5g)的安全性。
[Translation] Main research purpose: According to the relevant bioequivalence test regulations, Ornidazole Tablets (trade name: Tiberal®, specification: 0.5g) with OrPha Swiss GmbH as the licensee was selected as the reference preparation. The test preparation Ornidazole Capsules (specification: 0.25g) produced by Co., Ltd. was subjected to a bioequivalence test for fasting and postprandial administration in humans, to compare whether the absorption rate and degree of absorption of the test preparation were different from those of the reference preparation. Within acceptable limits, the bioequivalence of the two formulations under fasting and postprandial dosing conditions was evaluated.
Secondary research objectives: To observe the safety of the test preparation ornidazole capsules (specification: 0.25g) and the reference preparation ornidazole tablets (trade name: Tiberal®, specification: 0.5g) orally by healthy volunteers.