/ RecruitingNot Applicable 氯巴占口服混悬液(10 mg/5mL和2.5 mg/mL,20mg)在健康受试者中空腹及餐后条件下的单剂量、两周期、双交叉生物等效性试验
[Translation] Single-dose, two-period, double-crossover bioequivalence study of clobazam oral suspension (10 mg/5 mL and 2.5 mg/mL, 20 mg) in healthy subjects under fasting and fed conditions
考察空腹及餐后条件下单次口服20mg由上海爱的发制药有限公司提供的氯巴占口服混悬液(受试制剂,商品名:Tapclob®,规格:10mg/5mL)或单次口服20mg由Lundbeck Pharmaceuticals LLC持证的氯巴占口服混悬液(参比制剂,商品名:Onfi®,规格:2.5mg/mL)的生物等效性。
[Translation] The bioequivalence of a single oral dose of 20 mg of clobazam oral suspension provided by Shanghai Aifa Pharmaceutical Co., Ltd. (test preparation, trade name: Tapclob®, strength: 10 mg/5 mL) or a single oral dose of 20 mg of clobazam oral suspension certified by Lundbeck Pharmaceuticals LLC (reference preparation, trade name: Onfi®, strength: 2.5 mg/mL) was investigated under fasting and postprandial conditions.
/ Not yet recruitingNot Applicable 美沙拉秦缓释颗粒在空腹及餐后条件下的人体生物等效性研究预试验
[Translation] A pilot study on the bioequivalence of mesalazine sustained-release granules in humans under fasting and fed conditions
考察健康受试者在空腹或餐后状态下,单次口服1袋由上海爱的发制药有限公司提供的美沙拉秦缓释颗粒(受试制剂,规格:1g,按美沙拉秦计)与相同状态下单次口服1 袋由Ferring S.A.S 持证的美沙拉秦缓释颗粒(参比制剂,商品名:Pentasa®,规格:1g,按美沙拉秦计)的药动学特征,比较制剂间药动学参数AUC和Cmax的差异,初步评估两制剂生物等效性。
[Translation] The pharmacokinetic characteristics of healthy subjects were investigated by taking a single bag of mesalazine sustained-release granules (test preparation, strength: 1g, calculated as mesalazine) provided by Shanghai Aifa Pharmaceutical Co., Ltd. orally under fasting or postprandial state and taking a single bag of mesalazine sustained-release granules (reference preparation, trade name: Pentasa®, strength: 1g, calculated as mesalazine) certified by Ferring S.A.S. orally under the same state. The differences in pharmacokinetic parameters AUC and Cmax between the two preparations were compared, and the bioequivalence of the two preparations was preliminarily evaluated.
/ Not yet recruitingNot Applicable 非诺贝特胶囊在空腹和餐后条件下的单剂量、两周期、双交叉人体生物等效性研究
[Translation] A single-dose, two-period, double-crossover bioequivalence study of fenofibrate capsules in humans under fasting and fed conditions
本试验旨在研究单次空腹和餐后口服上海爱的发制药有限公司研制、生产的非诺贝特胶囊(0.2g)的药代动力学特征;以Abbott Laboratories Limited持证的非诺贝特胶囊(力平之®,200 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 investigate the pharmacokinetic characteristics of fenofibrate capsules (0.2 g) developed and produced by Shanghai Aifa Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using fenofibrate capsules (Lipingzhi®, 200 mg) certified by Abbott Laboratories Limited as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
100 Clinical Results associated with Shanghai Aidefa Pharmacy Co. Ltd.
0 Patents (Medical) associated with Shanghai Aidefa Pharmacy Co. Ltd.
100 Deals associated with Shanghai Aidefa Pharmacy Co. Ltd.
100 Translational Medicine associated with Shanghai Aidefa Pharmacy Co. Ltd.