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MechanismCysLT antagonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date20 Feb 1998 |
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MechanismBacterial DNA gyrase inhibitors [+1] |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date01 Jan 1998 |
/ CompletedNot Applicable 仿制药盐酸丙卡特罗颗粒与原研药盐酸丙卡特罗颗粒(Meptin®)在中国健康受试者体内空腹及餐后状态下的生物等效性研究
[Translation] Bioequivalence study of the generic drug Procaterol Hydrochloride Granules and the original drug Procaterol Hydrochloride Granules (Meptin®) in Chinese healthy volunteers under fasting and fed conditions
以四川大冢制药有限公司生产的盐酸丙卡特罗颗粒(规格:25μg,0.25 g/袋)为受试制剂,按生物等效性研究的有关规定,以 Otsuka Pharmaceutical Co.,Ltd.生产的盐酸丙卡特罗颗粒 (规格:0.01%,100 g/瓶,商品名:Meptin®) 为参比制剂,考察两种制剂在健康受试者体内的药代动力学特征,对空腹及餐后条件下受试制剂和参比制剂的生物等效性进行评价。 次要试验目的:评估受试制剂盐酸丙卡特罗颗粒(规格: 25μg,0.25 g/袋)与参比制剂盐酸丙卡特罗颗粒 (规格:0.01%,100 g/瓶,商品名:Meptin®) 在健康受试者中的安全性和耐受性。
[Translation] Procaterol Hydrochloride Granules (Specification: 25μg, 0.25 g/bag) produced by Sichuan Otsuka Pharmaceutical Co., Ltd. was used as the test preparation. According to the relevant provisions of bioequivalence studies, Procaterol Hydrochloride Granules (Specification: 0.01%, 100 g/bottle, trade name: Meptin®) produced by Otsuka Pharmaceutical Co., Ltd. was used as the reference preparation. The pharmacokinetic characteristics of the two preparations in healthy subjects were investigated, and the bioequivalence of the test preparation and the reference preparation under fasting and postprandial conditions was evaluated. Secondary study objective: To evaluate the safety and tolerability of the test preparation Procaterol Hydrochloride Granules (Specification: 25μg, 0.25 g/bag) and the reference preparation Procaterol Hydrochloride Granules (Specification: 0.01%, 100 g/bottle, trade name: Meptin®) in healthy subjects.
/ CompletedNot Applicable 仿制药盐酸丙卡特罗颗粒与原研药盐酸丙卡特罗颗粒(Meptin®)在中国健康受试者体内空腹及餐后状态下的生物等效性预备研究
[Translation] Preliminary bioequivalence study of the generic Procaterol Hydrochloride Granules and the original Procaterol Hydrochloride Granules (Meptin®) in healthy Chinese subjects under fasting and fed conditions
主要试验目的:以四川大冢制药有限公司生产的盐酸丙卡特罗颗粒(规格:0.01%,50 g/瓶)为受试制剂,按生物等效性研究的有关规定,以Otsuka Pharmaceutical Co.,Ltd.生产的盐酸丙卡特罗颗粒(规格:0.01%,100 g/瓶,商品名:Meptin®)为参比制剂,考察两种制剂在空腹及餐后条件下的相对生物利用度,对受试制剂和参比制剂的生物等效性进行初步评价,为临床用药正式试验提供参考数据。
次要试验目的:评估盐酸丙卡特罗颗粒相比参比制剂在健康受试者中的安全性和耐受性。
[Translation] Main purpose of the study: Procaterol hydrochloride granules (specification: 0.01%, 50 g/bottle) produced by Sichuan Otsuka Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence study, Procaterol hydrochloride granules (specification: 0.01%, 100 g/bottle, trade name: Meptin®) produced by Otsuka Pharmaceutical Co., Ltd. were used as the reference preparation to investigate the relative bioavailability of the two preparations under fasting and postprandial conditions, and to conduct a preliminary evaluation of the bioequivalence of the test preparation and the reference preparation, so as to provide reference data for formal clinical drug trials.
Secondary purpose of the study: To evaluate the safety and tolerability of Procaterol hydrochloride granules compared with the reference preparation in healthy subjects.
/ RecruitingNot Applicable 仿制药盐酸氨溴索胶囊(坦静 30mg)与原研药盐酸氨溴索片(沐舒坦 30mg)在中国健康志愿者体内餐后生物等效性研究
[Translation] Postprandial bioequivalence study of generic ambroxol hydrochloride capsules (Tanjing 30mg) and original ambroxol hydrochloride tablets (Mucosolvan 30mg) in healthy Chinese volunteers
以四川大冢制药有限公司生产的盐酸氨溴索胶囊(规格:30mg/粒,商品名:坦静®)为受试制剂,按生物等效性研究的有关规定,以Boehringer Ingelheim France公司生产的盐酸氨溴索片(规格:30mg/片,商品名:沐舒坦®)为参比制剂,考察两种制剂的生物利用度,对受试制剂和参比制剂的生物等效性进行评价,为临床用药提供参考数据。
[Translation] Ambroxol hydrochloride capsules (specification: 30 mg/capsule, trade name: Tanjing®) produced by Sichuan Otsuka Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence study, ambroxol hydrochloride tablets (specification: 30 mg/tablet, trade name: Mucosolvan®) produced by Boehringer Ingelheim France were used as the reference preparation. The bioavailability of the two preparations was investigated, and the bioequivalence of the test preparation and the reference preparation was evaluated to provide reference data for clinical use.
100 Clinical Results associated with Sichuan Otsuka Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Sichuan Otsuka Pharmaceutical Co. Ltd.
100 Deals associated with Sichuan Otsuka Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Sichuan Otsuka Pharmaceutical Co. Ltd.