[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of acetaminophen ibuprofen tablets in Chinese healthy participants under fasting/fed conditions
(1)主要研究目的:中国健康参与者空腹/餐后状态下,口服单剂量对乙酰氨基酚布洛芬片(受试制剂T,兰西哈三联制药有限公司生产,规格:每片含对乙酰氨基酚250mg,布洛芬125mg)与对乙酰氨基酚布洛芬片(参比制剂R,GLaxosmithkLine Consumer HeaLthcare HoLdings US LLC持证,商品名:AdviL DuaL Action With Acetaminophen®,规格:每片含对乙酰氨基酚250mg,布洛芬125mg)后,考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
(2)次要研究目的:观察受试制剂和参比制剂在健康参与者中的安全性。
[Translation] (1) Primary study objective: To investigate the absorption rate and extent of the test preparation and the reference preparation under fasting and postprandial conditions after oral administration of a single dose of acetaminophen ibuprofen tablets (test preparation T, produced by Lanxiha Sanlian Pharmaceutical Co., Ltd., specification: each tablet contains 250 mg acetaminophen and 125 mg ibuprofen) and acetaminophen ibuprofen tablets (reference preparation R, licensed by Glaxosmithk Line Consumer Healthcare Homes US LLC, trade name: AdviL DuaL Action With Acetaminophen®, specification: each tablet contains 250 mg acetaminophen and 125 mg ibuprofen) to healthy Chinese participants, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
(2) Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy participants.