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MechanismCGRP antagonists |
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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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MechanismTrkA antagonists |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项评估健康试验参与者空腹及餐后条件下口服BR005-036C片的药代动力学临床研究
[Translation] A clinical study evaluating the pharmacokinetics of BR005-036C tablets administered orally to healthy participants under fasting and postprandial conditions.
评估空腹及餐后条件下口服BR005-036C片,在健康成年受试者中的药代动力学特征
[Translation] Pharmacokinetic characteristics of BR005-036C tablets administered orally under fasting and postprandial conditions in healthy adult subjects.
[14C]BR005-036C在中国成年男性健康参与者中的物质平衡研究
[Translation] [14C]BR005-036C A Study on Material Balance in Healthy Adult Male Participants in China
主要研究目的:1.评估健康试验参与者单次口服[14C] BR005-036C后排泄物中的总放射性,获得人体放射性回收率数据及主要排泄途径;2.评估健康试验参与者单次口服[14C] BR005-036C后血浆、尿液和粪便的放射性代谢物谱,鉴定主要代谢产物,确定BR005-036C在人体内的生物转化途径;3.评估男性健康试验参与者单次口服[14C]BR005-036C后,全血和血浆中的总放射性,获得全血和血浆总放射性的药代动力学参数,并考察全血和血浆中总放射性的分配比。次要研究目的:1.定量分析健康试验参与者血浆中BR005-036C及其代谢产物(如适用)的药代动力学特征 2. 评估[14C]BR005-036C在健康成年试验参与者中单次口服给药的安全性
[Translation] Primary objectives: 1. To evaluate the total radioactivity in excrement of healthy participants after a single oral dose of [14C]BR005-036C, and to obtain data on human radioactivity recovery and the main excretion pathway; 2. To evaluate the radiometabolite profiles of plasma, urine, and feces of healthy participants after a single oral dose of [14C]BR005-036C, identify the main metabolites, and determine the biotransformation pathway of BR005-036C in humans; 3. To evaluate the total radioactivity in whole blood and plasma of male healthy participants after a single oral dose of [14C]BR005-036C, obtain pharmacokinetic parameters of total radioactivity in whole blood and plasma, and investigate the partition ratio of total radioactivity in whole blood and plasma. Secondary objectives: 1. To quantitatively analyze the pharmacokinetic characteristics of BR005-036C and its metabolites (if applicable) in the plasma of healthy participants; 2. To evaluate the safety of a single oral dose of [14C]BR005-036C in healthy adult participants.
一项评估健康受试者空腹条件下口服四种BR005-036C片剂的相对生物利用度研究
[Translation] A study to evaluate the relative bioavailability of four oral BR005-036C tablets in healthy subjects under fasting conditions
评估空腹条件下口服相同剂量的片剂B、片剂C、片剂D与片剂A相比,在健康成年受试者中的相对生物利用度
[Translation] To evaluate the relative bioavailability of Tablets B, C, and D compared with Tablet A at the same dose in healthy adult subjects under fasting conditions
100 Clinical Results associated with Brise Pharmaceuticals Co., Ltd.
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