NCT02273466已完成1 期
Pharmacokinetics of 50 mg Desipramine Daily, Given Orally Over 7 Days With and Without Concomitant Administration of 175 mg Crobenetine, Given as a 6 Hrs i.v. Infusion (One Hour Loading Dose Directly Followed by a Five Hours Maintenance Dose). A Randomized, Placebo Controlled, Single Blind (for Crobenetine), Two-way Cross Over Trial in Healthy Male Subjects
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
- 24
- 主要终点
- Area under the concentration time curve for desipramine at steady state (AUC,ss)
研究概览
简要总结
To assess the steady state pharmacokinetics of Desipramine with/without concomitant administration of Crobenetine.
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
- Single
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 should be healthy males, range from 21 to 50 years of age and their bodymass index (BMI) be within 18.5 to 29.9 kg/m
- •In accordance with Good Clinical Practice and local legislation all volunteers will have given their written informed consent prior to admission to the study.
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant 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 at least one month or less than ten half-lives of the respective drug before enrolment in the study
- •Use of any drugs which might influence the results of the trial (within one week prior to administration or during the trial)
- •Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
- •Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (>= 100 mL within four weeks prior to administration or during the trial)
- •Excessive physical activities (within the last week before the study)
- •Any laboratory value outside the reference range of clinical relevance
- •Cytochrome P450 2D6 poor metaboliser (to be determined by phenotyping or genotyping)
研究组 & 干预措施
Desipramine alone
Active Comparator
干预措施: Desipramine tablet (Drug)
Desipramine alone
Active Comparator
干预措施: Placebo infusion (Drug)
Desipramine with Crobenetine
Experimental
干预措施: Desipramine tablet (Drug)
Desipramine with Crobenetine
Experimental
干预措施: Crobenetine infusion (Drug)
结局指标
主要结局
Area under the concentration time curve for desipramine at steady state (AUC,ss)
时间窗: up to 168 hours after start of drug administration
Maximum plasma concentration of desipramine at steady state (Cmax,ss)
时间窗: up to 168 hours after start of drug administration
次要结局
- Apparent terminal half-live in plasma (t1/2)(up to 168 hours after start of drug administration)
- Area under the concentration time curve from zero time to time of last quantifiable drug concentration (AUC0-tz)(up to 168 hours after start of drug administration)
- Area under the concentration time curve from zero time extrapolated to infinity(AUC0-infinity)(up to 168 hours after start of drug administration)
- Number of subjects with adverse events(up to 8 days after last drug administration)
- Total clearance (CL)(up to 168 hours after start of drug administration)
- Observed concentration of crobenetine (C,h)(1 and 6 hours after start of infusion)
- Number of subjects with clinically significant findings in laboratory tests(up to 8 days after last drug administration)
- Individual time courses of plasma concentrations(up to 168 hours after start of drug administration)
- Time to reach maximum concentration of desipramine at steady state (tmax,ss)(up to 168 hours after start of drug administration)
- Apparent terminal rate constant (λz)(up to 168 hours after start of drug administration)
- Mean residence time (MRT)(up to 168 hours after start of drug administration)
- Apparent volume of distribution (V)(up to 168 hours after start of 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 12-lead ECG(up to 8 days after last drug administration)
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