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Inactive Indication- |
Drug Highest PhasePhase 2/3 |
First Approval Ctry. / Loc.- |
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MechanismSARS-CoV 3CLpro inhibitors |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
ADC189颗粒与ADC189片在中国成年男性健康受试者中的药代动力学比较研究
[Translation] Comparative Study on the Pharmacokinetics of ADC189 Granules and ADC189 Tablets in Chinese Adult Male Healthy Subjects
主要目的:比较ADC189颗粒(制剂1)与ADC189片(制剂2)在中国成年男性健康受试者空腹条件下单次给药后的药代动力学特征。次要目的:评估单剂量口服ADC189颗粒(制剂1)和ADC189片(制剂2)在中国成年男性健康受试者中的安全性。
[Translation] Main purpose: To compare the pharmacokinetic characteristics of ADC189 granules (Preparation 1) and ADC189 tablets (Preparation 2) after single administration in Chinese adult male healthy subjects under fasting conditions. Secondary objective: To evaluate the safety of a single oral dose of ADC189 granules (Formulation 1) and ADC189 tablets (Formulation 2) in healthy Chinese adult male subjects.
[14C]ADC189在中国健康受试者体内的物质平衡I期临床试验
[Translation] [14C]ADC189 Phase I Clinical Trial on Material Balance in Chinese Healthy Subjects
主要研究目的:(1)定量分析健康受试者口服[14C]ADC189后,排泄物中的总放射性量,获得人体放射性的累积排泄率和主要排泄途径;(2)鉴定健康受试者口服[14C]ADC189后人体内的主要代谢产物,确定主要生物转化途径和主要代谢产物(接近或大于10%总放射性AUC);(3)考察健康受试者单次口服[14C]ADC189后,全血和血浆中总放射性的分配情况和血浆总放射性的药代动力学。
次要研究目的:(1)采用已验证的液相色谱-串联质谱法(LC-MS/MS)定量分析血浆中的ADC189、ADC189-I07及其他主要代谢产物(如适用)的浓度,获得ADC189、ADC189-I07及其他主要代谢产物(如适用)的药动学参数;(2)评价[14C]ADC189单次给药后健康受试者的安全性。
[Translation] Main research purposes: (1) Quantitatively analyze the total radioactivity in the excretion of healthy subjects after oral administration of [14C]ADC189, and obtain the cumulative excretion rate and main excretion pathways of radioactivity in the human body; (2) Identify healthy subjects after oral administration of [14C]ADC189. The main metabolites in the human body after 14C]ADC189, determine the main biotransformation pathways and main metabolites (close to or greater than 10% of the total radioactivity AUC); (3) Examine the whole blood of healthy subjects after a single oral administration of [14C]ADC189 and the distribution of total radioactivity in plasma and the pharmacokinetics of total plasma radioactivity.
Secondary research purposes: (1) Use the proven liquid chromatography-tandem mass spectrometry (LC-MS/MS) to quantitatively analyze the concentrations of ADC189, ADC189-I07 and other major metabolites (if applicable) in plasma, and obtain ADC189 , pharmacokinetic parameters of ADC189-I07 and other major metabolites (if applicable); (2) Evaluate the safety of [14C]ADC189 in healthy subjects after a single dose.
A Phase I Study to Investigate the Absorption, Metabolism, Excretion, and Safety of [(14)C]ADC189 in Healthy Chinese Male Volunteers
This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants.
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