[Translation] A single-center, randomized, open-label, single-dose, double-period, cross-over trial design to evaluate the bioequivalence of Chinese healthy subjects taking orally administered acetaminophen dihydrocodeine tablets on an empty stomach and after meals
以持证商为Accord UK Ltd的氨酚双氢可待因片(商品名:Co-dydramol®,规格:对乙酰氨基酚500 mg,酒石酸双氢可待因10 mg)为参比制剂,以陕西九州制药有限责任公司研究生产的氨酚双氢可待因片(规格:对乙酰氨基酚500 mg,酒石酸双氢可待因10 mg)为受试制剂,通过单中心、随机、开放、单剂量、双周期、交叉试验设计,评价两制剂在健康受试者空腹和餐后状态下单次口服给药的人体生物等效性。
[Translation] The paracetamol dihydrocodeine tablets (trade name: Co-dydramol®, specifications: acetaminophen 500 mg, dihydrocodeine tartrate 10 mg) from the licensee Accord UK Ltd were used as the reference preparation. The paracetamol dihydrocodeine tablet (specification: acetaminophen 500 mg, dihydrocodeine tartrate 10 mg) researched and produced by Shaanxi Jiuzhou Pharmaceutical Co., Ltd. was used as the test preparation. Dose, two-period, cross-over experimental design, to evaluate the human bioequivalence of single oral administration of two preparations in healthy subjects under fasting and fed state.