NCT05998304已完成1 期
Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] Yiqibuvir in Healthy Male Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples)
研究概览
简要总结
This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] Yiqibuvir.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •signing of informed consent
- •Weight: Body mass index (BMI) is 19.0~28.0 kg/m2
- •Subjects are able to communicate well with the investigators and be able to complete the trial according to the process
排除标准
- •Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations
- •Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive
- •Positive results from urine drug screen test
- •Donate blood or lose blood 400 mL or more within 3 month prior to dosing
- •Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication
- •History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection
研究组 & 干预措施
[14C] Yiqibuvir
Experimental
Eligible healthy male subjects received a single oral 600 mg (radioactivity of 100µCi) dose of [14C] Yiqibuvir
干预措施: [14C] Yiqibuvir (Drug)
结局指标
主要结局
Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples)
时间窗: up to 18 days
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
次要结局
- Identification of the Proportion of different metabolites to determine biotransformation pathway of Yiqibuvir(up to 18 days)
- Quantitive analysis of the concentrations of Yiqibuvir and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data(up to 18 days)
- Number of adverse events (AE) experienced by subjects(up to 18 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
ADME Study of [14C] Antaitavir Hasophate in Healthy Male SubjectsHealthy Male SubjectsNCT05446233Sunshine Lake Pharma Co., Ltd.6
已完成
1 期
A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy SubjectsHealthyNCT01048203Active Biotech AB6
已完成
1 期
ADME Study of [14C]-Jaktinib in Healthy Male SubjectsHealthy Adult Male VolunteersNCT05150717Suzhou Zelgen Biopharmaceuticals Co.,Ltd6
Unknown
1 期
Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Healthy Adult Male SubjectsHealthy Male VolunteersNCT04476394Sihuan Pharmaceutical Holdings Group Ltd.6
已完成
1 期
A Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male SubjectsHealthy Male SubjectsNCT05369858CSPC ZhongQi Pharmaceutical Technology Co., Ltd.6