[Translation] A randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of aceclofenac tablets (100mg) under fasting and postprandial dosing conditions in healthy Chinese subjects
主要研究目的:按有关生物等效性试验的规定,选择Almirall, S.A.生产的醋氯芬酸片(商品名:Airtal®,规格:100mg)为参比制剂,对江苏吉贝尔药业股份有限公司生产的受试制剂醋氯芬酸片(规格:100mg)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醋氯芬酸片(规格:100mg)和参比制剂醋氯芬酸片(商品名:Airtal®,规格:100mg)的安全性。
[Translation] Main research purpose: According to the relevant bioequivalence test regulations, choose Aceclofenac Tablets (trade name: Airtal®, specification: 100mg) produced by Almirall, S.A. The produced test preparation Aceclofenac Tablets (specification: 100mg) was administered to human body bioequivalence test on an empty stomach and after meals, and compared the absorption rate and degree of absorption of the test preparation and the reference preparation. The bioequivalence of the two formulations was evaluated under fasting and postprandial dosing conditions, within acceptable limits.
Secondary research objectives: To observe the safety of the test preparation Aceclofenac Tablets (specification: 100mg) and the reference preparation Aceclofenac Tablets (trade name: Airtal®, strength: 100mg) orally by healthy volunteers.