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MechanismCYP17A1 inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date28 Apr 2011 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date22 Jul 2005 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date25 Jan 1956 |
/ CompletedNot Applicable 柑橘黄酮片在空腹及餐后条件下的人体生物等效性预试验
[Translation] Preliminary human bioequivalence studies of citrus flavonoid tablets under fasting and postprandial conditions.
主要研究目的:
本试验为探索性生物等效性预试验,其目的是对健康试验参与者在空腹及餐后状态下,单次口服由湖南慧泽生物医药科技有限公司提供的柑橘黄酮片【受试制剂T,规格:500mg(以总黄酮计)】与相同状态下单次口服由Les Laboratoires Servier持证的柑橘黄酮片【参比制剂R,商品名:爱脉朗®,规格:500mg(以总黄酮计)】拟定待测物的药动学特征进行探索,探索拟定待测物的分析方法,探索拟定待测物Cmax和AUC的生物等效性情况,为未来正式生物等效性试验临床研究方案设计以及代测物分析方法提供依据。
次要研究目的:
观察单次口服受试制剂或参比制剂在健康试验参与者中的安全性。
[Translation] Primary Objective: This study is an exploratory bioequivalence preliminary trial. Its purpose is to investigate the pharmacokinetic characteristics of a single oral dose of citrus flavonoid tablets (test formulation T, strength: 500 mg (total flavonoids)) provided by Hunan Huize Biomedical Technology Co., Ltd., and a single oral dose of citrus flavonoid tablets (reference formulation R, trade name: Aimailang®, strength: 500 mg (total flavonoids)) certified by Les Laboratoires Servier under the same fasting and postprandial conditions. The study also aims to explore analytical methods for the proposed analyte and investigate the bioequivalence of the proposed analyte's Cmax and AUC, providing a basis for the design of future formal bioequivalence clinical trial protocols and the analytical methods for analytes.
Secondary Objective: To observe the safety of a single oral dose of either the test formulation or the reference formulation in healthy participants.
/ CompletedNot Applicable [Translation] Bioequivalence studies of methotrexate tablets in humans under fasting and postprandial conditions
研究健康试验参与者在空腹及餐后条件下,单次口服由湖南慧泽生物医药科技有限公司提供的甲氨蝶呤片(受试制剂,规格:2.5mg)与相同条件下单次口服由Pfizer Japan Inc.持证的甲氨蝶呤片(参比制剂,商品名:METHOTREXATE®,规格:2.5mg)的药动学特征,评价两制剂间的生物等效性,为该受试制剂注册申请提供依据。
[Translation] The study investigated the pharmacokinetic characteristics of a single oral dose of methotrexate tablets (test formulation, strength: 2.5 mg) provided by Hunan Huize Biomedical Technology Co., Ltd., and a single oral dose of methotrexate tablets (reference formulation, trade name: METHOTREXATE®, strength: 2.5 mg) certified by Pfizer Japan Inc. under the same conditions, under fasting and postprandial conditions. The aim was to evaluate the bioequivalence between the two formulations and provide a basis for the registration application of the test formulation.
[Translation] Human pharmacokinetic studies of HXHTT024
主要研究目的:本研究以广西善合百升科技有限公司提供的HXHTT024(规格:10mg、20mg)为受试制剂,以Besins Healthcare Benelux持证的黄体酮软胶囊(商品名:安琪坦®,规格:0.1g)为对照制剂,考察空腹条件下受试制剂和对照制剂的药动学特征。
次要研究目的:观察单次给药HXHTT024(规格:10mg、20mg)受试制剂或黄体酮软胶囊(商品名:安琪坦®,规格:0.1g)对照制剂在健康试验参与者中的安全性。
[Translation] Primary objective: This study investigated the pharmacokinetic characteristics of the test and control formulations under fasting conditions using HXHTT024 (10mg and 20mg) provided by Guangxi Shanhe Baisheng Technology Co., Ltd., and progesterone soft capsules (trade name: Anqitan®, 0.1g) certified by Besins Healthcare Benelux.
Secondary objective: To observe the safety of a single dose of the test formulation HXHTT024 (10mg and 20mg) or the control formulation progesterone soft capsules (trade name: Anqitan®, 0.1g) in healthy participants.
100 Clinical Results associated with Hunan Huize Biomedical Technology Co., Ltd.
0 Patents (Medical) associated with Hunan Huize Biomedical Technology Co., Ltd.
100 Deals associated with Hunan Huize Biomedical Technology Co., Ltd.
100 Translational Medicine associated with Hunan Huize Biomedical Technology Co., Ltd.