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Clinical Trials associated with SY-5007[14C]SY-5007在中国健康成年男性受试者体内的物质平衡研究
[Translation] Study on the material balance of [14C]SY-5007 in healthy adult male subjects in China
主要目的:1.定量分析健康受试者口服[14C]SY-5007后全血与血浆总放射性、获得血浆中总放射性的PK参数,并考察全血和血浆中的总放射性分配情况。2.定量分析健康受试者口服[14C]SY-5007后排泄物中的总放射性,获得人体放射性回收率数据和主要排泄途径。3.鉴定健康受试者口服[14C]SY-5007后人体血、尿、粪样的代谢物谱和主要代谢产物,确定主要生物转化途径。次要目的:1.采用已验证的液相色谱质谱联用法(LS-MS/MS)方法定量分析血浆中SY-5007及其代谢物(如适用)的浓度,获得SY-5007及其代谢物(如适用)的PK参数。2.观察[14C]SY-5007单次给药后受试者的安全性。
[Translation] Primary objectives: 1. Quantitatively analyze the total radioactivity in whole blood and plasma after oral administration of [14C]SY-5007 to healthy subjects, obtain the PK parameters of total radioactivity in plasma, and investigate the distribution of total radioactivity in whole blood and plasma. 2. Quantitatively analyze the total radioactivity in excreta after oral administration of [14C]SY-5007 to healthy subjects, obtain the data of human radioactivity recovery rate and the main excretion pathway. 3. Identify the metabolite profile and main metabolites of human blood, urine and feces samples after oral administration of [14C]SY-5007 to healthy subjects, and determine the main biotransformation pathway. Secondary objectives: 1. Quantitatively analyze the concentration of SY-5007 and its metabolites (if applicable) in plasma using a validated liquid chromatography-mass spectrometry (LS-MS/MS) method, and obtain the PK parameters of SY-5007 and its metabolites (if applicable). 2. Observe the safety of subjects after a single dose of [14C]SY-5007.
An Open-Label, Single-Center, Single-Dose, Phase I Study to Assess the Mass Balance of [14C] SY-5007 in Healthy Male Subjects in China
This is a single-center, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered orally.
A Randomized, Open-label, Two-period, Self-controlled Study to Evaluate the Effect of Oral Rifampicin or Itraconazole on the Pharmacokinetics of SY-5007 Tablets in Healthy Subjects
This study is a single-center, open-lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of SY-5007 Oral administration. It is planned to enroll 28 healthy subjects and assign them to two parallel test groups, Group A (SY-5007 combined with Itraconazole) and Group B (SY-5007 combined with Rifampicin).
100 Clinical Results associated with SY-5007
100 Translational Medicine associated with SY-5007
100 Patents (Medical) associated with SY-5007
100 Deals associated with SY-5007