/ RecruitingNot Applicable 美沙拉秦缓释颗粒在空腹和餐后条件下的单剂量、四周期、两序列完全重复交叉人体生物等效性研究
[Translation] A single-dose, four-cycle, two-sequence fully replicate crossover human bioequivalence study of mesalazine sustained-release granules under fasting and postprandial 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、生产的美沙拉秦缓释颗粒(1 g)的药代动力学特征;以Ferring GmbH生产的美沙拉秦缓释颗粒(Pentasa®,1 g)为参比制剂,比较受试制剂和参比制剂中药动学参数Cmax和AUC,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of mesalazine sustained-release granules (1 g) developed and produced by Shanghai Aifa Pharmaceutical Co., Ltd., after a single fasting and postprandial oral administration. Mesalazine sustained-release granules (Pentasa®, 1 g) produced by Ferring GmbH were used as a reference formulation. The pharmacokinetic parameters Cmax and AUC of the test formulation and the reference formulation were compared to evaluate the bioequivalence of the two formulations in humans.
/ CompletedNot 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.
/ CompletedNot 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.
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.