[Translation] A randomized, open-label, two-formulation, single-dose, two-period, double-crossover bioequivalence study of celecoxib capsules in healthy study participants.
主要目的:以陕西西岳制药有限公司研制的塞来昔布胶囊(规格:0.2 g)为受试制剂,以Viatris Pharmaceuticals LLC生产的塞来昔布胶囊(商品名:西乐葆®,规格:0.2 g)为参比制剂,考察两制剂在空腹状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。 次要目的:评价中国健康研究参与者单次空腹口服塞来昔布胶囊受试制剂和参比制剂后的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic parameters and relative bioavailability of celecoxib capsules (0.2 g) manufactured by Shaanxi Xiyue Pharmaceutical Co., Ltd. as the test formulation and celecoxib capsules (trade name: Celebrex®, 0.2 g) manufactured by Viatris Pharmaceuticals LLC as the reference formulation after a single fasting administration, and to evaluate the bioequivalence of the two formulations. Secondary objective: To evaluate the safety of a single fasting oral administration of celecoxib capsules (test and reference formulations) to participants in the Chinese Health Study.