[Translation] A single-center, open-label, balanced, randomized, single-dose, two-period, double-crossover bioequivalence study of amoxicillin granules in healthy subjects under fasting and fed conditions
比较空腹及餐后给药条件下,海南通用三洋药业有限公司提供的阿莫西林颗粒(125 mg/袋)与Laboratoire GlaxoSmithKline持证的阿莫西林干混悬剂(125 mg/5 ml,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。同时评价空腹及餐后给药条件下,海南通用三洋药业有限公司提供的阿莫西林颗粒(125 mg/袋)与Laboratoire GlaxoSmithKline持证的阿莫西林干混悬剂(125 mg/5 ml,商品名:Clamoxyl)的安全性。
[Translation] To compare the differences in the extent and rate of absorption of amoxicillin granules (125 mg/bag) provided by Hainan General Sanyo Pharmaceutical Co., Ltd. and amoxicillin dry suspension (125 mg/5 ml, trade name: Clamoxyl) certified by Laboratoire GlaxoSmithKline in healthy adults under fasting and postprandial administration conditions, and evaluate their bioequivalence. At the same time, the safety of amoxicillin granules (125 mg/bag) provided by Hainan General Sanyo Pharmaceutical Co., Ltd. and amoxicillin dry suspension (125 mg/5 ml, trade name: Clamoxyl) certified by Laboratoire GlaxoSmithKline under fasting and postprandial administration conditions was evaluated.