NCT02259985已完成1 期
Investigation of the Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose of 1 mg in Healthy Male Subjects (3-way Cross-over)
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
- 15
- 主要终点
- Time to maximum concentration (tmax)
研究概览
简要总结
food interaction, pharmacokinetics, safety and tolerability
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
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •all participants in the study will range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-index)
- •written informed consent in accordance with Good Clinical Practica and local legislation
排除标准
- •Subjects will be excluded from the study if the results of the medical examination or laboratory tests are judged by the investigator to differ significantly from normal clinical values
- •Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- •Subjects with known history of orthostatic hypotension, fainting spells or blackouts
- •Subjects with chronic or relevant acute infections
- •Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Subjects who have taken a drug with a long half-life (>= 24 hours) within one month before enrolment in the study
- •Subjects who received any other drugs which might influence the results of the trial during the week previous the start of the study
- •Subjects who have participated in another study with an investigational drug within the last 2 months preceding this study
- •Subjects who are unable to refrain from smoking on study days
- •Subjects who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
- •Subjects who drink more than 60 g of alcohol per day
- •Subjects who are dependent on drugs
- •Subjects who have donated blood (>= 100 ml) within the last 4 weeks
- •Subjects who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
研究组 & 干预措施
Itasetron tablet fasted
Active Comparator
干预措施: Itasetron tablet (Drug)
Itasetron infusion fasted
Active Comparator
干预措施: Itasetron infusion (Drug)
Itasetron tablet fed
Experimental
干预措施: Itasetron tablet (Drug)
Itasetron tablet fed
Experimental
干预措施: high fat breakfast (Other)
结局指标
主要结局
Time to maximum concentration (tmax)
时间窗: up to 48 hours after drug administration
Area under the concentration time curve from zero to infinity (AUC0-inf)
时间窗: up to 48 hours after drug administration
Maximum concentration of drug in plasma
时间窗: up to 48 hours after drug administration
次要结局
- Area under the concentration time curve from zero to to the time of last data point above limit of quantitation (AUC0-tlast)(up to 48 hours after drug administration)
- Cmax/AUC ratio(up to 48 hours after drug administration)
- Apparent volume of distribution during the terminal phase λz (Vz)(up to 48 hours after drug administration)
- Number of participants with clinically significant findings in laboratory tests(up to 8 days after last drug administration)
- Mean residence time in the body (MRTtot)(up to 48 hours after drug administration)
- Elimination half-life (t1/2)(up to 48 hours after drug administration)
- Total clearance from plasma (CLtot)(up to 48 hours after drug administration)
- Apparent volume of distribution after intravascular dose at steady state (Vss)(up to 48 hours after drug administration)
- Number of participants with clinically significant findings in vital signs(up to 8 days after last drug administration)
- Number of participants with clinically significant findings in ECG(up to 8 days after last drug administration)
- Number of participants with adverse events(up to 8 days after last drug administration)
研究者
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