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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date01 Jan 1994 |
头孢泊肟酯片在中国健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹和餐后状态下的生物等效性研究
[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of cefpodoxime proxetil tablets in Chinese healthy subjects under fasting and fed conditions
预试验:
主要目的:本研究以康芝药业股份有限公司生产的头孢泊肟酯片(规格:0.1g/片,剂量:0.1g)为受试制剂,以Daiichi Sankyo Co., Ltd.生产的头孢泊肟酯片(商品名:BANAN®,规格0.1g/片,剂量0.1g)为参比制剂,考察空腹和餐后条件下受试制剂和参比制剂在健康受试者体内的药代动力学参数和个体内变异系数,验证血中药物浓度分析方法、采血时间、清洗期时间间隔等设置的合理性。
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。
正式试验:
主要目的:本研究以康芝药业股份有限公司生产的头孢泊肟酯片(规格:0.1g/片,剂量:0.1g)为受试制剂,以Daiichi Sankyo Co., Ltd.生产的头孢泊肟酯片(商品名:BANAN®,规格0.1g/片,剂量0.1g)为参比制剂,评估受试制剂和参比制剂在空腹和餐后状态下给药时的生物等效性。
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] Preliminary study:
Main purpose: This study used Cefpodoxime Proxetil Tablets (Specification: 0.1g/tablet, Dose: 0.1g) produced by Kangzhi Pharmaceutical Co., Ltd. as the test preparation, and Cefpodoxime Proxetil Tablets (Trade name: BANAN®, Specification 0.1g/tablet, Dose 0.1g) produced by Daiichi Sankyo Co., Ltd. as the reference preparation to investigate the pharmacokinetic parameters and intra-individual coefficient of variation of the test preparation and reference preparation in healthy subjects under fasting and postprandial conditions, and to verify the rationality of the blood drug concentration analysis method, blood collection time, washout period time interval and other settings.
Secondary purpose: Observe the safety of the test preparation and reference preparation in healthy subjects.
Formal trial:
Main purpose: This study uses Cefpodoxime Proxetil Tablets (specification: 0.1g/tablet, dose: 0.1g) produced by Kangzhi Pharmaceutical Co., Ltd. as the test preparation and Cefpodoxime Proxetil Tablets (trade name: BANAN®, specification 0.1g/tablet, dose 0.1g) produced by Daiichi Sankyo Co., Ltd. as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation when administered in the fasting and fed state.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Guangdong Yuanning Pharmaceutical Co., Ltd.
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