[Translation] A single-center, randomized, open-label, fasting and fed single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of ibuprofen suspension in healthy Chinese adult subjects
主要研究目的:
考察单次口服200mg(空腹/餐后)受试制剂布洛芬混悬液(规格:100mL:2g,成都倍特得诺药业有限公司生产)与参比制剂布洛芬混悬液(美林®,规格:100mL:2g,上海强生制药有限公司生产),在中国健康人体内的相对生物利用度,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:
评价受试制剂和参比制剂单次口服200mg(空腹/餐后)在中国成年健康受试者中的安全性。
[Translation] Main research objectives:
To investigate the relative bioavailability of a single oral dose of 200 mg (fasting/after meals) of the test preparation ibuprofen suspension (specification: 100 mL: 2 g, produced by Chengdu Betadino Pharmaceutical Co., Ltd.) and the reference preparation ibuprofen suspension (Mei Lin®, specification: 100 mL: 2 g, produced by Shanghai Johnson Pharmaceutical Co., Ltd.) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug.
Secondary research objectives:
To evaluate the safety of a single oral dose of 200 mg (fasting/after meals) of the test preparation and the reference preparation in healthy Chinese adult subjects.