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骨化三醇软胶囊在健康受试者中的单剂量、随机、开放、交叉、两周期空腹和餐后人体生物等效性试验
[Translation] Single-dose, randomized, open-label, crossover, two-period fasting and postprandial human bioequivalence studies of calcitriol soft capsules in healthy subjects
主要目的:以广州艾格生物科技有限公司的骨化三醇软胶囊(规格:0.25μg)为受试制剂,以 Roche Pharma(Schweiz)公司的骨化三醇软胶囊(规格:0.25μg,商品名:Rocaltrol®)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Calcitriol soft capsules (specification: 0.25 μg) from Guangzhou Aige Biotechnology Co., Ltd. : Rocaltrol®) is the reference preparation, and the bioequivalence of the two preparations in healthy human body is investigated according to the relevant provisions of the bioequivalence test.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
一项在中国健康成年志愿者中评估空腹和餐后条件下单次口服托吡司特片人体生物等效性研究
[Translation] A human bioequivalence study to assess the human bioequivalence of a single oral dose of topiramast under fasting and postprandial conditions in healthy Chinese adult volunteers
主要目的:
比较空腹及餐后给药条件下,江苏知原药业有限公司生产的托吡司特片(60 mg/片)与Fujiyakuhin Co., Ltd.(日本富士药品株式会社)托吡司特片(60 mg/片,商品名:URIADEC®)在健康人群中吸收程度和速度的差异。
次要目的:
评价空腹及餐后条件下,江苏知原药业有限公司生产的托吡司特片(60 mg/片)的安全性和耐受性。
[Translation] main purpose:
Comparison of topiralast tablets (60 mg/tablet) produced by Jiangsu Zhiyuan Pharmaceutical Co., Ltd. and Fujiyakuhin Co., Ltd. (Japan Fuji Pharmaceutical Co., Ltd.) topiralast tablets ( 60 mg/tablet, trade name: URIADEC®) differences in the extent and rate of absorption in healthy individuals.
Secondary purpose:
To evaluate the safety and tolerability of Topiralast tablets (60 mg/tablet) produced by Jiangsu Zhiyuan Pharmaceutical Co., Ltd. under fasting and postprandial conditions.
阿普斯特片在中国健康受试者中的一项随机、开放、单次给药、两制剂、两序列、两周期的生物等效性研究
[Translation] A randomized, open-label, single-dose, two-dose, two-sequence, two-cycle bioequivalence study of Apremilast tablets in healthy Chinese subjects
观察受试者单次口服30mg受试制剂阿普斯特片(规格:30mg/片,兆科药业(广州)有限公司生产)与参比制剂阿普斯特片(商品名:Otezla,规格:30mg/片,Celgene公司生产)在体内的药代动力学特征,评价空腹与餐后两种制剂的生物等效性。同时,观察受试者口服受试制剂和参比制剂后的安全性。
[Translation] The subjects were observed to take a single oral dose of 30 mg of the test preparation Apremilast (specification: 30 mg/tablet, produced by Zhaoke Pharmaceutical (Guangzhou) Co., Ltd.) and the reference preparation Apremilast (trade name: Otezla, specification : 30mg/tablet, produced by Celgene Company) in vivo pharmacokinetic characteristics, evaluating the bioequivalence of the two preparations on an empty stomach and after meals. At the same time, observe the safety of subjects after oral administration of test preparations and reference preparations.
100 Clinical Results associated with Guangzhou EGGBIO Biology Co., Ltd.
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