乌帕替尼缓释片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of upadacitinib extended-release tablets in humans under fasting and fed conditions
本研究考察健康男性和女性受试者在空腹及餐后条件下,单次口服由江苏飞马药业有限公司提供的乌帕替尼缓释片(受试制剂,规格:15mg)与相同条件下单次口服由AbbVie Deutschland GmbH & Co. KG持证的乌帕替尼缓释片(参比制剂,商品名:Rinvoq®,规格:15mg)的药动学特征,评价两制剂间的生物等效性及安全性,为该受试制剂的注册申请提供依据。
[Translation] This study investigated the pharmacokinetic characteristics of upadacitinib sustained-release tablets (test preparation, strength: 15 mg) provided by Jiangsu Pegasus Pharmaceutical Co., Ltd. and upadacitinib sustained-release tablets (reference preparation, trade name: Rinvoq®, strength: 15 mg) approved by AbbVie Deutschland GmbH & Co. KG in healthy male and female subjects under fasting and postprandial conditions, and evaluated the bioequivalence and safety of the two preparations to provide a basis for the registration application of the test preparation.
布瑞哌唑片在中国健康人群中单次给药的人体生物等效性临床试验
[Translation] A human bioequivalence clinical trial of brepirazole tablets in healthy Chinese subjects after single administration
主要目的:以持证商为Otsuka Pharmaceutical Co Ltd的布瑞哌唑片(商品名:Rexulti,规格:2mg)为参比制剂,以江苏飞马药业有限公司研发的布瑞哌唑片(规格:2mg)为受试制剂,评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the two preparations in Chinese healthy subjects in the fasting and postprandial states, using the brexiprazole tablets (trade name: Rexulti, specification: 2 mg) of the licensee Otsuka Pharmaceutical Co Ltd as the reference preparation and the brexiprazole tablets (specification: 2 mg) developed by Jiangsu Pegasus Pharmaceutical Co Ltd as the test preparation.
Secondary objective: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.
中国健康志愿者空腹和餐后单次口服美洛昔康片的随机、开放、两序列、两周期、双交叉设计的生物等效性研究
[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of meloxicam tablets in Chinese healthy volunteers after fasting or feeding
研究空腹及餐后单次口服美洛昔康片受试制剂(普利洛®,7.5 mg/片,江苏飞马药业有限公司)与美洛昔康片参比制剂(MOBEC ®,7.5 mg/片,Boehringer Ingelheim Pharma GmbH& Co.KG)后美洛昔康在中国健康志愿者体内的PK(Pharmacokinetics,药代动力学)行为,评价空腹及餐后口服两种制剂的生物等效性。
次要目的:
评价中国健康志愿者单次口服美洛昔康片受试制剂和参比制剂后的安全性。
[Translation] To study the PK (Pharmacokinetics) behavior of meloxicam in healthy Chinese volunteers after a single oral administration of the test formulation of meloxicam tablets (Prilo®, 7.5 mg/tablet, Jiangsu Pegasus Pharmaceutical Co., Ltd.) and the reference formulation of meloxicam tablets (MOBEC®, 7.5 mg/tablet, Boehringer Ingelheim Pharma GmbH & Co.KG) on an empty stomach and after a meal, and to evaluate the bioequivalence of the two formulations after an empty stomach and after a meal.
Secondary objective:
To evaluate the safety of the test formulation and reference formulation of meloxicam tablets in healthy Chinese volunteers after a single oral administration.
100 Clinical Results associated with Jiangsu Feima Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Jiangsu Feima Pharmaceutical Co., Ltd.