Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] Antaitavir Hasophate in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate
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] Antaitavir Hasophate.
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] Antaitavir Hasophate
Eligible healthy male subjects received a single oral 100 mg (radioactivity of 200µCi) dose of [14C] Antaitavir Hasophate
干预措施: [14C] Antaitavir Hasophate (Drug)
结局指标
主要结局
Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate
时间窗: up to 15 days
To investigate the pharmacokinetics of total radioactivity in plasma after oral \[14C\] Antaitavir Hasophate in healthy subjects, and the distribution ratio of total radioactivity in whole blood and plasma
Cumulative excretion of [14C] Antaitavir Hasophate -related material (radioactivity in plasma, urine and fecal samples)
时间窗: up to 15 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 Antaitavir Hasophate(up to 15 days)
- Quantitive analysis of the concentrations of Antaitavir Hasophate and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data(up to 15 days)
- Number of adverse events (AE) experienced by subjects(up to 15 days)