[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of aceclofenac tablets (100 mg) in Chinese healthy subjects under fasting and fed conditions
以合肥英太制药有限公司提供的醋氯芬酸片为受试制剂(规格:100mg)(T),以Almirall,S.A.为持证商的醋氯芬酸片(商品名:Airtal®,规格:100mg)为参比制剂(R),评估健康受试者在空腹及餐后状态下单次口服受试制剂和参比制剂的药代动力学特征,评价两种制剂的人体生物等效性。
[Translation] Aceclofenac tablets provided by Hefei Yingtai Pharmaceutical Co., Ltd. were used as the test preparation (specification: 100 mg) (T), and Aceclofenac tablets (trade name: Airtal®, specification: 100 mg) licensed by Almirall, S.A. were used as the reference preparation (R). The pharmacokinetic characteristics of the test preparation and the reference preparation after a single oral administration in healthy subjects under fasting and postprandial conditions were evaluated, and the bioequivalence of the two preparations in humans was evaluated.