[Translation] To evaluate the single-center, open-label, randomized, single-dose, two-cycle, two-sequence, fasting/postprandial status of the test preparation paracetamol and the reference preparation paracetamol in healthy adult subjects. Crossover Bioequivalence Study
主要研究目的:考察单次单剂量口服(空腹/餐后)受试制剂氨酚曲马多片(规格:盐酸曲马多37.5mg/对乙酰氨基酚325mg(1片),多多药业有限公司生产)与参比制剂氨酚曲马多片(ULTRACET®,规格:盐酸曲马多37.5mg/对乙 酰氨基酚325mg(1片),JANSSEN PHARMACEUTICALSINC生产),在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。次要研究目的:评价空腹、餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main research purpose: To investigate a single single-dose oral (fasting/after meal) test preparation paracetamol and tramadol tablets (specification: tramadol hydrochloride 37.5mg/acetaminophen 325mg (1 tablet), Duoduo Pharmaceutical Co., Ltd. production) and the reference preparation paracetamol and tramadol tablets (ULTRACET®, specification: tramadol hydrochloride 37.5mg/ acetaminophen 325mg (1 tablet), produced by JANSSEN PHARMACEUTICALSINC), the relative bioavailability of healthy humans in China, The pharmacokinetic parameters of the two preparations were analyzed, and the bioequivalence of the two preparations was evaluated to provide a reference for the application and clinical use of the drug. Secondary study objectives: To evaluate the safety of a single oral dose of the test preparation and reference preparation on an empty stomach and after a meal in Chinese adult healthy subjects.