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MechanismCYP3A4 inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date07 Dec 2004 |
阿莫西林克拉维酸钾干混悬剂在健康受试者中随机、开放、两周期、双交叉的空腹/餐后状态下生物等效性试验
[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of amoxicillin-clavulanate potassium dry suspension in healthy subjects under fasting/fed conditions
主要目的:
研究阿莫西林克拉维酸钾干混悬剂受试制剂和参比制剂在空腹/餐后状态下的药动学特征,通过预试验验证阿莫西林和克拉维酸钾在人体血浆中的分析方法、评估变异程度、优化采样时间,为正式试验提供参考依据;通过正式试验评价两制剂的生物等效性。
次要目的:
观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose:
To study the pharmacokinetic characteristics of the test preparation and reference preparation of amoxicillin-clavulanate potassium dry suspension in fasting/postprandial state, to verify the analytical method of amoxicillin and clavulanate potassium in human plasma, evaluate the degree of variation, and optimize the sampling time through preliminary tests, to provide a reference basis for formal tests; to evaluate the bioequivalence of the two preparations through formal tests.
Secondary purpose:
To observe the safety of the test preparation and reference preparation in healthy subjects.
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