/ CompletedNot Applicable 一项随机、开放、单剂量、两周期、双交叉、空腹和餐后给药临床研究,评价盐酸多西环素片与Vibramycin在中国健康成年受试者中的生物等效性
[Translation] A randomized, open-label, single-dose, two-period, double-crossover, fasting and fed administration clinical study to evaluate the bioequivalence of doxycycline hydrochloride tablets and vibramycin in healthy Chinese adult subjects
主要目的:
以广州康和药业有限公司生产的盐酸多西环素片(100mg(按C22H24N2O8计))受试制剂,按生物等效性试验的有关规定,与Pfizer Japan Inc持有的盐酸多西环素片(商品名:Vibramycin,规格:0.1g(按C22H24N2O8计))为参比制剂,进行生物等效性试验,比较两种制剂在空腹和餐后条件下单次给药的生物等效性。
次要目的:
评估单剂口服受试制剂(盐酸多西环素片,T)和参比制剂(Vibramycin,R)在中国健康成年受试者中的安全性。
[Translation] Main purpose:
Based on the relevant provisions of bioequivalence test, the test preparation of doxycycline hydrochloride tablets (100mg (calculated as C22H24N2O8)) produced by Guangzhou Kanghe Pharmaceutical Co., Ltd. was compared with the reference preparation of doxycycline hydrochloride tablets (trade name: Vibramycin, specification: 0.1g (calculated as C22H24N2O8)) held by Pfizer Japan Inc. to conduct a bioequivalence test to compare the bioequivalence of the two preparations under fasting and postprandial conditions.
Secondary purpose:
Evaluate the safety of a single oral dose of the test preparation (doxycycline hydrochloride tablets, T) and the reference preparation (Vibramycin, R) in healthy adult subjects in China.
100 Clinical Results associated with Guangzhou Kanghe Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Guangzhou Kanghe Pharmaceutical Co., Ltd.
100 Deals associated with Guangzhou Kanghe Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Guangzhou Kanghe Pharmaceutical Co., Ltd.