Investigation of Metabolism and Pharmacokinetics of Talsaclidine After Administration of Single Oral and Single Intravenous Dose of 20 mg of [14C]-Labelled Talsaclidine to 6 Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- [C14]-radioactivity concentration in plasma
研究概览
简要总结
Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Age range from 50 to 65 years
- •Participants should be within 20% of their normal weight (Broca-Index)
- •Written informed consent in accordance with Good Clinical Practice and local legislation
排除标准
- •Results of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from normal clinical values
- •Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Disease of the central nervous system (such as epilepsy) or with psychiatric disorders
- •Known history of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (≥ 24 hours) within one month before enrolment in the study
- •Intake of any other drugs which might influence the results of the trial during the week previous the start of the study
- •Participation in another study with an investigational drug within the last 2 months preceding this study
- •Unability to refrain from smoking on study days
- •Volunteers who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
- •Volunteers who drink more than 40 g of alcohol per day
- •Volunteers who are dependent on drugs
- •Blood donation ((≥ 100 ml) within the last 4 weeks
- •Excessive physical activities (e.g. competitive sports) within the last week before the study
研究组 & 干预措施
[14C]talsaclidine, oral
single dose of 20 mg oral solution
干预措施: [14C]talsaclidine, oral (Drug)
[14C]talsaclidine, iv
single dose of 20 mg intravenous (iv) infusion
干预措施: [14C]talsaclidine, iv (Drug)
结局指标
主要结局
[C14]-radioactivity concentration in plasma
时间窗: up to 96 hours after drug administration
Maximum concentration of the analyte in plasma (Cmax)
时间窗: up to 96 hours after drug administration
Drug absorption (fa) based on radioactivity
时间窗: up to 96 hours after drug administration
[C14]-radioactivity concentration in urine
时间窗: up to 96 hours after drug administration
Terminal half-life (t1/2)
时间窗: up to 96 hours after drug administration
Time to reach maximum plasma concentration (tmax)
时间窗: up to 96 hours after drug administration
[C14]-radioactivity concentration in blood
时间窗: up to 96 hours after drug administration
Absolute bioavailability based on AUC
时间窗: up to 96 hours after drug administration
Area under the plasma concentration-time curve (AUC)
时间窗: up to 96 hours after drug administration
次要结局
- Number of subjects with clinically significant findings in electrocardiogram(up to 8 days after last drug administration)
- Apparent clearance (CL)(up to 96 hours after drug administration)
- Plasma protein binding of the [14C] radioactivity(up to 96 hours after drug administration)
- Urinary excretion (Ae)(up to 96 hours after drug administration)
- Number of subjects with adverse events(up to 8 days after last drug administration)
- Apparent volume of distribution (Vz/f))(up to 96 hours after drug administration)
- Mean residence time (MRT)(up to 96 hours after drug administration)
- Number of subjects with clinically significant findings in vital signs(up to 8 days after last drug administration)
- Number of subjects with clinically significant findings in laboratory tests(up to 8 days after last drug administration)