/ CompletedNot Applicable 洛索洛芬钠片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of loxoprofen sodium tablets in healthy volunteers under fasting and fed conditions
考察健康受试者在空腹条件及餐后条件下,单次口服由江苏鹏鹞药业有限公司提供的洛索洛芬钠片(受试制剂T,规格:60mg)与相同条件下单次口服由第一三共制药(上海)有限公司持证的洛索洛芬钠片(参比制剂R,商品名:乐松®,规格:60mg)的药动学特征,评价两制剂的生物等效性及安全性,为该受试制剂注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of loxoprofen sodium tablets (test preparation T, strength: 60 mg) provided by Jiangsu Pengyao Pharmaceutical Co., Ltd. after a single oral administration in healthy subjects under fasting and postprandial conditions and loxoprofen sodium tablets (reference preparation R, trade name: Lesong®, strength: 60 mg) certified by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd. after a single oral administration under the same conditions, to evaluate the bioequivalence and safety of the two preparations and to provide a basis for the registration application of the test preparation.
/ CompletedNot Applicable 健康受试者在空腹及餐后状态下单次口服富马酸酮替芬片的人体生物等效性试验
[Translation] Bioequivalence study of a single oral dose of ketotifen fumarate tablets in healthy subjects under fasting and fed conditions
主要目的:
以江苏鹏鹞药业有限公司生产的富马酸酮替芬片为受试制剂(T),以Novartis Pharma Schweiz AG生产的富马酸酮替芬片(Zaditen®)为参比制剂(R),评估健康受试者在空腹及餐后状态下单次口服受试制剂和参比制剂的人体生物利用度,评价两种制剂的生物等效性。
次要目的:
考察健康受试者口服受试制剂和参比制剂后的安全性。
[Translation] Main purpose:
Using ketotifen fumarate tablets produced by Jiangsu Pengyao Pharmaceutical Co., Ltd. as the test preparation (T), and ketotifen fumarate tablets (Zaditen®) produced by Novartis Pharma Schweiz AG as the reference preparation (R), evaluate the human bioavailability of the test preparation and the reference preparation after a single oral administration in healthy subjects in the fasting and postprandial state, and evaluate the bioequivalence of the two preparations.
Secondary purpose:
Investigate the safety of the test preparation and the reference preparation after oral administration in healthy subjects.
/ CompletedNot Applicable 卡马西平片(200mg)随机、开放、四周期、完全重复交叉在健康人体空腹和餐后条件下生物等效性试验
[Translation] A randomized, open-label, four-period, completely repeated crossover bioequivalence study of carbamazepine tablets (200 mg) in healthy volunteers under fasting and fed conditions
1)评价在空腹和餐后给药条件下,受试制剂卡马西平片(江苏鹏鹞药业有限公司生产)200mg和参比制剂卡马西平片(商品名:得理多®,北京诺华制药有限公司生产)200mg在中国健康受试者中的生物等效性;
2)观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] 1) To evaluate the bioequivalence of the test preparation carbamazepine tablets (produced by Jiangsu Pengyao Pharmaceutical Co., Ltd.) 200 mg and the reference preparation carbamazepine tablets (trade name: Delito®, produced by Beijing Novartis Pharmaceutical Co., Ltd.) 200 mg in healthy Chinese subjects under fasting and postprandial administration conditions;
2) To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Jiangsu Pengyao Pharmaceuticals, Inc.
0 Patents (Medical) associated with Jiangsu Pengyao Pharmaceuticals, Inc.
100 Deals associated with Jiangsu Pengyao Pharmaceuticals, Inc.
100 Translational Medicine associated with Jiangsu Pengyao Pharmaceuticals, Inc.