|
|
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date27 May 1983 |
Target- |
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
BCM475口溶膜与布瑞哌唑片在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验
[Translation] Human bioequivalence trial of BCM475 orally dissolving film and bripipiprazole tablets in Chinese healthy volunteers under fasting and postprandial conditions
主要目的:
观察空腹和餐后条件下布瑞哌唑口溶膜在中国健康成人受试者中单次口服给药后布瑞哌唑的体内药代动力学过程,估算相应的药代动力学参数,并以Otsuka Pharmaceutical Co Ltd持证的布瑞哌唑片(商品名:REXULTI®)为参比制剂,分别进行生物等效性评价。
次要目的:
1. 观察布瑞哌唑口溶膜(受试制剂)和布瑞哌唑片(商品名:REXULTI®,参比制剂)在健康人体中的安全性;
2. 比较空腹条件下受试制剂不同给药方式(给水条件和不给水条件)对相对生物利用度的影响;
3. 评价布瑞哌唑口溶膜(受试制剂,不给水条件)的口感(适口性)、砂砾感、溶化时间、黏膜粘附性和刺激性。
[Translation] main purpose:
To observe the in vivo pharmacokinetic process of bripipiprazole after a single oral administration of bripipiprazole in Chinese healthy adult subjects under fasting and postprandial conditions, estimate the corresponding pharmacokinetic parameters, and Bioequivalence evaluations were conducted using Bripipiprazole Tablets (trade name: REXULTI®) licensed by Otsuka Pharmaceutical Co Ltd as the reference preparation.
Secondary purpose:
1. Observe the safety of Bripiprazole orally dissolving film (test preparation) and Bripipiprazole tablets (trade name: REXULTI®, reference preparation) in healthy humans;
2. Compare the effects of different administration methods (water supply conditions and no water supply conditions) on the relative bioavailability of the test preparation under fasting conditions;
3. Evaluate the mouthfeel (palatability), gritty feel, dissolution time, mucosal adhesion and irritation of the orally dissolvable film of Bripipiprazole (test preparation, without water supply).
BCM347口溶膜与盐酸氨溴索口服溶液在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验
[Translation] Human bioequivalence test of BCM347 oral dissolving film and ambroxol hydrochloride oral solution in Chinese healthy volunteers under fasting and postprandial conditions
主要目的:
观察BCM347口溶膜在中国健康受试者中单次口服给药后的盐酸氨溴索体内动力学过程,估算相应的药代动力学参数,并以Opella Healthcare Austria GmbH持证、欧盟上市的盐酸氨溴索口服溶液(商品名:Mucosolvan)为参比制剂,进行生物等效性评价。
次要目的:
1. 观察BCM347口溶膜(受试制剂)和盐酸氨溴索口服溶液(商品名:Mucosolvan®,参比制剂)在健康人体中的安全性;
2、比较空腹条件下受试制剂不同给药方式(给水条件和不给水条件)对相对生物利用度的影响;
3、对受试者服用BCM347口溶膜(受试制剂,不给水条件)和盐酸氨溴索口服溶液(参比制剂)的口感(适口性)进行评价;
4、 考察和记录BCM347口溶膜(受试制剂,不给水条件)在口腔的溶化时间、黏膜粘附性和刺激性。
[Translation] main purpose:
Observe the in vivo kinetic process of ambroxol hydrochloride after a single oral administration of BCM347 orally dissolving film in Chinese healthy subjects, estimate the corresponding pharmacokinetic parameters, and use hydrochloric acid licensed by Opella Healthcare Austria GmbH and marketed in the EU. Ambroxol oral solution (trade name: Mucosolvan) is the reference preparation for bioequivalence evaluation.
Secondary purpose:
1. Observe the safety of BCM347 oral dissolving film (test preparation) and ambroxol hydrochloride oral solution (trade name: Mucosolvan®, reference preparation) in healthy humans;
2. Compare the effects of different administration methods (water supply conditions and no water supply conditions) on the relative bioavailability of the test preparation under fasting conditions;
3. Evaluate the taste (palatability) of subjects taking BCM347 oral dissolving film (test preparation, without water supply) and ambroxol hydrochloride oral solution (reference preparation);
4. Observe and record the dissolution time, mucosal adhesion and irritation of BCM347 oral dissolving film (test preparation, without water supply) in the oral cavity.
布立西坦缓释片与布立西坦片在健康受试者中的药代动力学及生物利用度研究
[Translation] Study on Pharmacokinetics and Bioavailability of Briracetam Sustained-release Tablets and Briracetam Tablets in Healthy Subjects
主要目的:比较布立西坦缓释片和布立西坦片在健康受试者中空腹/餐后条件下的单次/多次给药药代动力学特征以及人体相对生物利用度,同时考察布立西坦缓释片和布立西坦片间的生物等效性。
次要目的:观察布立西坦缓释片和布立西坦片在健康人体中的安全性。
[Translation] Main purpose: To compare the single/multiple administration pharmacokinetic characteristics and relative bioavailability of Briracetam Sustained-release Tablets and Briracetam Tablets in healthy subjects under fasting/postprandial conditions, and to investigate at the same time Bioequivalence between Brivaracetam Extended-Release Tablets and Brivaracetam Tablets.
Secondary purpose: To observe the safety of Briracetam Sustained-release Tablets and Briracetam Tablets in healthy subjects.
100 Clinical Results associated with Shanghai Bocimed Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shanghai Bocimed Pharmaceutical Co., Ltd.
100 Deals associated with Shanghai Bocimed Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shanghai Bocimed Pharmaceutical Co., Ltd.