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MechanismSGLT2 inhibitors |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date16 Jan 2024 |
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MechanismProton pump inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date21 Jun 2023 |
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Inactive Indication- |
Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
[14C]XZP-3621在中国健康受试者体内的物质平衡I期临床试验
[Translation] [14C] Phase I Clinical Trial of XZP-3621 Material Balance in Chinese Healthy Subjects
主要目的:
定量分析健康受试者单次口服[14C]XZP-3621后排泄物的总放射性,获得人体内物质平衡数据及主要排泄途径;
定量分析健康受试者单次口服[14C]XZP-3621后全血与血浆总放射性、获得血浆中总放射性的药代动力学参数,并考察全血和血浆总放射性的分配情况;
考察健康受试者单次口服[14C]XZP-3621后血浆、尿液和粪便中的放射性代谢物谱,并鉴定主要代谢产物,提供XZP-3621在人体内主要代谢途径及消除途径。
次要目的:
采用已验证的液相色谱串联质谱法(LC-MS/MS)定量分析血浆中XZP-3621、代谢产物XZP-5089及其他代谢产物(如适用)的浓度,获得血浆中XZP-3621、代谢产物XZP-5089及其他代谢产物(如适用)的药代动力学参数。
评估健康受试者单次口服[14C]XZP-3621的安全性。
[Translation] main purpose:
Quantitatively analyze the total radioactivity in the excreta of healthy subjects after a single oral administration of [14C]XZP-3621, and obtain the material balance data and main excretion routes in the human body;
Quantitatively analyze the total radioactivity in whole blood and plasma after a single oral administration of [14C]XZP-3621 in healthy subjects, obtain the pharmacokinetic parameters of total radioactivity in plasma, and investigate the distribution of total radioactivity in whole blood and plasma;
Investigate the spectrum of radioactive metabolites in plasma, urine and feces after a single oral administration of [14C]XZP-3621 in healthy subjects, identify the main metabolites, and provide the main metabolic pathway and elimination pathway of XZP-3621 in the human body.
Secondary purpose:
The concentration of XZP-3621, metabolite XZP-5089 and other metabolites (if applicable) in plasma was quantitatively analyzed by a validated liquid chromatography tandem mass spectrometry (LC-MS/MS), and XZP-3621, metabolites in plasma were obtained Pharmacokinetic parameters of XZP-5089 and other metabolites (if applicable).
To evaluate the safety of single oral administration of [14C]XZP-3621 in healthy subjects.
一项在健康受试者中评价伊曲康唑或利福平或艾司奥美拉唑对XZP-3621片的药代动力学影响的药物-药物相互作用研究
[Translation] A drug-drug interaction study evaluating the effects of itraconazole or rifampicin or esomeprazole on the pharmacokinetics of XZP-3621 tablets in healthy subjects
主要目的:
1. 评估在健康志愿者中伊曲康唑对XZP-3621片的药代动力学影响;
2. 评估在健康志愿者中利福平对XZP-3621片的药代动力学影响;
3. 评估在健康志愿者中艾司奥美拉唑对XZP-3621片的药代动力学影响;
次要目的:
1. 评估在健康志愿者中XZP-3621单药以及联用伊曲康唑的安全性。
2. 评估在健康志愿者中XZP-3621单药以及联用利福平的安全性。
3. 评估在健康志愿者中XZP-3621单药以及联用艾司奥美拉唑的安全性。
[Translation] main purpose:
1. To evaluate the pharmacokinetic effects of itraconazole on XZP-3621 tablets in healthy volunteers;
2. To evaluate the effect of rifampicin on the pharmacokinetics of XZP-3621 tablets in healthy volunteers;
3. To evaluate the effect of esomeprazole on the pharmacokinetics of XZP-3621 tablets in healthy volunteers;
Secondary purpose:
1. To evaluate the safety of XZP-3621 alone and in combination with itraconazole in healthy volunteers.
2. To evaluate the safety of XZP-3621 alone and in combination with rifampicin in healthy volunteers.
3. To evaluate the safety of XZP-3621 alone and in combination with esomeprazole in healthy volunteers.
[14C]吡罗西尼在中国男性健康受试者体内的物质平衡与生物转化研究
[Translation] Substance balance and biotransformation of [14C]pirociclib in Chinese male healthy subjects
考察[14C]吡罗西尼在健康受试者全血和血浆的分配情况以及全血和血浆中总放射性的药代动力学特征;
定量分析健康受试者单次口服[14C]吡罗西尼后排泄物的总放射性,获得人体内物质平衡数据及主要排泄途径;
评估健康受试者单次口服[14C]吡罗西尼的安全性。
[Translation] To investigate the distribution of [14C]pirociclib in whole blood and plasma of healthy subjects and the pharmacokinetic characteristics of total radioactivity in whole blood and plasma;
Quantitatively analyze the total radioactivity of the excreta of healthy subjects after a single oral administration of [14C]pirociclib, and obtain the data of mass balance in the human body and the main excretion route;
To evaluate the safety of a single oral dose of [14C]pirociclib in healthy subjects.
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