[Translation] A single-center, open-label, single-dose, mass balance and biotransformation clinical trial to investigate the absorption, metabolism and excretion of 100 mg/100 μCi [14C]-fadanafil in healthy Chinese male subjects
主要目的: 1.考察健康受试者单次口服[14C] -复达那非后血浆和全血中的分配情况和血浆中总放射性的药代动力学; 2.定量分析健康受试者口服[14C]-复达那非后排泄物的总放射性,获得人体内回收率数据及主要排泄途径; 3.测定健康受试者口服[14C]- 复达那非后血浆、尿液和粪便中的放射性代谢物谱并鉴定主要代谢产物,提供复达那非在人体内主要代谢途径数据。
次要目的: 1.采用已验证的液质联用技术(LC-MS/MS)定量分析血浆中复达那非原型药物及代谢产物浓度,获得血浆中复达那非及代谢产物的药代动力学参数; 2.观察健康受试者单次口服[14C]- 复达那非的安全性。
[Translation] Main objectives: 1. To investigate the distribution of [14C]-fadanafil in plasma and whole blood and the pharmacokinetics of total radioactivity in plasma after a single oral administration of [14C]-fadanafil to healthy subjects; 2. To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]-fadanafil to healthy subjects, and obtain the data of recovery rate and main excretion pathway in human body; 3. To determine the radioactive metabolite spectrum in plasma, urine and feces of healthy subjects after oral administration of [14C]-fadanafil and identify the main metabolites, and provide data on the main metabolic pathways of fadanafil in human body.
Secondary objectives: 1. To quantitatively analyze the concentration of fadanafil parent drug and metabolites in plasma using the validated liquid chromatography-mass spectrometry (LC-MS/MS) technology, and obtain the pharmacokinetic parameters of fadanafil and metabolites in plasma; 2. To observe the safety of a single oral administration of [14C]-fadanafil to healthy subjects.