[Translation] A single-dose, fasting and postprandial, two-agent, two-cycle, two-sequence, randomized, open-label, self-crossover mean bioequivalence study in healthy subjects
主要研究目的:本研究以浙江亚太药业股份有限公司的塞来昔布胶囊(规格:200mg)为受试制剂,Pfizer Pharmaceuticals LLC生产(辉瑞制药有限公司分包装)的塞来昔布胶囊(商品名:西乐葆®;规格:200mg)为参比制剂,评价两制剂生物等效的可能性。
次要研究目的:评价空腹及餐后状态下单次口服塞来昔布胶囊在中国健康受试者中的安全性。
[Translation] Main research purposes: In this study, celecoxib capsules (specification: 200 mg) from Zhejiang Asia-Pacific Pharmaceutical Co., Ltd. were used as the test preparation, and celecoxib capsules (commercial product) produced by Pfizer Pharmaceuticals LLC (subpackaged by Pfizer Pharmaceuticals Co., Ltd.) were used as the test preparation. Name: Celebrex®; strength: 200 mg) as the reference preparation to evaluate the possibility of bioequivalence of the two preparations.
Secondary study objectives: To evaluate the safety of a single oral dose of celecoxib capsules in healthy Chinese subjects in fasting and postprandial states.