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阿奇霉素颗粒在空腹及餐后条件下的人体生物等效性试验
[Translation] Human bioequivalence test of azithromycin granules under fasting and postprandial conditions
本研究考察空腹及餐后条件下湖北潜江制药股份有限公司生产的受试制剂阿奇霉素颗粒(规格:100mg/袋)与PLIVA公司持证的参比制剂阿奇霉素干混悬剂(商品名:Sumamed(舒美特),规格:100mg/5ml)单次口服的药动学特征,比较其相对生物利用度,评价两制剂间的生物等效性,为该试验制剂一致性评价提供依据。
次要研究目的
评价单次口服100mg/袋的受试制剂阿奇霉素颗粒或参比制剂(商品名:Sumamed(舒美特),规格:100mg/5ml)在健康受试者中的安全性。
[Translation] In this study, the test preparation azithromycin granules (specification: 100 mg/bag) produced by Hubei Qianjiang Pharmaceutical Co., Ltd. and the reference preparation azithromycin dry suspension (trade name: Sumamed (trade name: Sumamed) certified by PLIVA Company were investigated under fasting and postprandial conditions. Sulmet), specification: 100mg/5ml), the pharmacokinetic characteristics of a single oral administration, the comparison of its relative bioavailability, the evaluation of the bioequivalence between the two preparations, and the basis for the consistency evaluation of the test preparations.
Secondary research purpose
To evaluate the safety of the test preparation azithromycin granules or reference preparation (trade name: Sumamed, specification: 100mg/5ml) in healthy subjects with a single oral dose of 100mg/bag.
100 Clinical Results associated with Hubei Qianjiang Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hubei Qianjiang Pharmaceutical Co., Ltd.
31 Dec 2002·Zhongguo Shenghua Yaowu Zazhi
A rapid assay of bacterial endotoxin in clindamycin phosphate injection
Author: Yu, Shenggang ; Zhou, Changjun ; Guo, Aiping
Interference test were made by clindamycin phosphate injection of different batch number and horseshoe crab reagent produced by different factories. When clindamycin phosphate injection was diluted to 2mg/mL, it had no interference to horseshoe crab reagent. Horseshoe crab reagents of sensitivity ≤0.5 EU/mL were used in the bacterial endotoxin assay. This method could substitute former pyrogen assay.
100 Deals associated with Hubei Qianjiang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hubei Qianjiang Pharmaceutical Co., Ltd.