[Translation] A single-center, open-label, randomized, single-dose, two-period, two-crossover bioequivalence study of amoxicillin granules in healthy subjects, in both fasting and postprandial states.
主要目的
比较空腹和餐后给药条件下,湖南安邦制药股份有限公司提供的阿莫西林颗粒(按C16H19N3O5S计0.125g)与GlaxoSmithKline Pharmaceuticals s.a./n.v.持证的阿莫西林干混悬剂(125mg/5ml,商品名:Clamoxyl)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,湖南安邦制药股份有限公司提供的阿莫西林颗粒(按C16H19N3O5S计0.125g)与GlaxoSmithKline Pharmaceuticals s.a./n.v.持证的阿莫西林干混悬剂(125mg/5ml,商品名:Clamoxyl)的安全性。
[Translation] Primary Objective: To compare the absorption rates and extent of amoxicillin granules (0.125 g, calculated as C16H19N3O5S) supplied by Hunan Anbang Pharmaceutical Co., Ltd. with those of amoxicillin dry suspension (125 mg/5 ml, trade name: Clamoxyl) certified by GlaxoSmithKline Pharmaceuticals S.A./n.v. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary Objective: To evaluate the safety of amoxicillin granules (0.125 g, calculated as C16H19N3O5S) supplied by Hunan Anbang Pharmaceutical Co., Ltd. with those of amoxicillin dry suspension (125 mg/5 ml, trade name: Clamoxyl) certified by GlaxoSmithKline Pharmaceuticals S.A./n.v. under fasting and postprandial administration conditions.