/ CompletedNot Applicable [Translation] Study on the bioequivalence of minocycline hydrochloride capsules in healthy volunteers
本试验旨在研究单次空腹口服北京海步医药科技有限公司研发、北京亚宝生物药业有限公司生产的盐酸米诺环素胶囊(50 mg)的药代动力学特征;以Pfizer Japan Inc.持证、生产的盐酸米诺环素胶囊(MINOMYCIN®,50 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This study aimed to study the pharmacokinetic characteristics of a single fasting oral dose of minocycline hydrochloride capsules (50 mg) developed by Beijing Haibu Pharmaceutical Technology Co., Ltd. and produced by Beijing Yabao Biopharmaceutical Co., Ltd.; minocycline hydrochloride capsules (MINOMYCIN®, 50 mg) licensed and produced by Pfizer Japan Inc. were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.
/ CompletedNot Applicable 布瑞哌唑片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of brepirazole tablets in healthy subjects under fasting and fed conditions
主要目的:比较空腹和餐后给药条件下,北京海步医药科技有限公司提供的布瑞哌唑片(2mg)与大冢制药株式会社持证的布瑞哌唑片(2mg,商品名:REXULTI®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的:评价空腹和餐后给药条件下,北京海步医药科技有限公司提供的布瑞哌唑片(2mg)与大冢制药株式会社持证的布瑞哌唑片(2mg,商品名:REXULTI®)在健康成年人群中的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of brepirazole tablets (2 mg) provided by Beijing Haibu Pharmaceutical Technology Co., Ltd. and brepirazole tablets (2 mg, trade name: REXULTI®) certified by Otsuka Pharmaceutical Co., Ltd. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of brepirazole tablets (2 mg) provided by Beijing Haibu Pharmaceutical Technology Co., Ltd. and brepirazole tablets (2 mg, trade name: REXULTI®) certified by Otsuka Pharmaceutical Co., Ltd. in healthy adults under fasting and postprandial administration conditions.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of agomelatine tablets in healthy volunteers
主要目的:本试验旨在研究单次空腹和餐后口服北京海步医药科技有限公司研制、石家庄龙泽制药股份有限公司生产的阿戈美拉汀片(25 mg)的药代动力学特征;以Les Laboratoires Servier Industrie生产的阿戈美拉汀片(维度新®,25 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
次要目的:观察受试制剂阿戈美拉汀片和参比制剂阿戈美拉汀片(维度新®)在健康受试者中的安全性。
[Translation] Primary objective: This study aims to study the pharmacokinetic characteristics of agomelatine tablets (25 mg) developed by Beijing Haibu Pharmaceutical Technology Co., Ltd. and produced by Shijiazhuang Longze Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; agomelatine tablets (Weixin®, 25 mg) produced by Les Laboratoires Servier Industrie were used as the reference preparation to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations and evaluate the bioequivalence of the two preparations in humans.
Secondary objective: To observe the safety of the test preparation agomelatine tablets and the reference preparation agomelatine tablets (Weixin®) in healthy subjects.
100 Clinical Results associated with Beijing Hope Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Beijing Hope Pharmaceutical Co., Ltd.