[Translation] A randomized, open-label, single-dose, three-sequence, three-cycle, partially repeated crossover bioequivalence study of amoxicillin-clavulanate potassium (14:1) dry suspension in healthy Chinese subjects under postprandial dosing conditions
主要研究目的:按有关生物等效性试验的规定,选择 GlaxoSmithklineK.K.为持证商的阿莫西林克拉维酸钾干糖浆(14:1)(商品名:クラバモックス®,规格:642.9mg(1.01g))为参比制剂,对上海海虹实业(集团)巢湖今辰药业有限公司生产的受试制剂阿莫西林克拉维酸钾(14:1)干混悬剂(规格:0.643g (C16H19N3O5S 0.6g 与 C8H9NO5 0.043g))进行餐后给药人体生物等效性试验,
比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂阿莫西林克拉维酸钾(14:1)干混悬剂(规格:0.643g (C16H19N3O5S 0.6g 与 C8H9NO5 0.043g))和参比制剂阿莫西林克拉维酸钾干糖浆(14:1)(商品名:クラバモックス®,规格:642.9mg(1.01g))的安全性。
[Translation] Main research purpose: According to the relevant bioequivalence test regulations, choose GlaxoSmithklineK.K. as the licensee of amoxicillin-clavulanate potassium dry syrup (14:1) (trade name: クラバモックス®, specification: 642.9mg ( 1.01g)) as the reference preparation, the test preparation amoxicillin-clavulanate potassium (14:1) dry suspension (specification: 0.643g) produced by Shanghai Haihong Industrial (Group) Chaohu Jinchen Pharmaceutical Co., Ltd. (C16H19N3O5S 0.6g and C8H9NO5 0.043g)) for postprandial administration of human bioequivalence test,
Compare whether the difference in the absorption rate and degree of absorption of the drug in the test preparation and the reference preparation is within an acceptable range, and evaluate the bioequivalence of the two preparations under postprandial administration conditions.
Secondary research objectives: To observe the oral administration of the test preparation amoxicillin-clavulanate potassium (14:1) dry suspension (specification: 0.643g (C16H19N3O5S 0.6g and C8H9NO5 0.043g)) and the reference preparation to healthy volunteers Safety of amoxicillin-clavulanate potassium dry syrup (14:1) (trade name: クラバモックス®, strength: 642.9mg (1.01g)).