[Translation] A single-center, randomized, open-label, single-dose, two-period, two-crossover bioequivalence study of acetaminophen-ibuprofen tablets in healthy participants in both fasting and postprandial states.
主要目的
比较空腹和餐后给药条件下,北京华素制药股份有限公司提供的对乙酰氨基酚布洛芬片(每片含对乙酰氨基酚250mg,布洛芬125mg)与Haleon US Holdings LLC持证的对乙酰氨基酚布洛芬片(每片含对乙酰氨基酚250mg,布洛芬125mg;商品名:Advil DUAL ACTION With Acetaminophen)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的
评价空腹和餐后给药条件下,北京华素制药股份有限公司提供的对乙酰氨基酚布洛芬片(每片含对乙酰氨基酚250mg,布洛芬125mg)与Haleon US Holdings LLC持证的对乙酰氨基酚布洛芬片(每片含对乙酰氨基酚250mg,布洛芬125mg;商品名:Advil DUAL ACTION With Acetaminophen)在健康成年人群中的安全性。
[Translation] Primary Objective: To compare the absorption rates and efficacy of acetaminophen-ibuprofen tablets (each tablet containing 250 mg acetaminophen and 125 mg ibuprofen) supplied by Beijing Huasu Pharmaceutical Co., Ltd., and acetaminophen-ibuprofen tablets (each tablet containing 250 mg acetaminophen and 125 mg ibuprofen; brand name: Advil DUAL ACTION With Acetaminophen) certified by Haleon US Holdings LLC in a healthy adult population under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary Objective: To evaluate the safety of acetaminophen-ibuprofen tablets (each tablet containing 250 mg acetaminophen and 125 mg ibuprofen) supplied by Beijing Huasu Pharmaceutical Co., Ltd., and acetaminophen-ibuprofen tablets (each tablet containing 250 mg acetaminophen and 125 mg ibuprofen; brand name: Advil DUAL ACTION With Acetaminophen) certified by Haleon US Holdings LLC in a healthy adult population under fasting and postprandial administration conditions.