NCT02269202已完成1 期
Pharmacokinetics of 7.5 mg Midazolam, Given Orally 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 Randomised, Single Blind, Two-way Crossover 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
- 20
- 主要终点
- Maximum observed concentration of midazolam in plasma (Cmax)
研究概览
简要总结
To assess the pharmacokinetics of midazolam with/without concomitant administration of crobenetine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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/m2
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 (except substitution therapy regarding thyroid gland)
- •Use of any drugs that 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
研究组 & 干预措施
Midazolam and crobenetine
Experimental
干预措施: Midazolam, tablet (Drug)
Midazolam and crobenetine
Experimental
干预措施: Crobenetine, i.v. infusion (Drug)
Midazolam and placebo
Placebo Comparator
干预措施: Midazolam, tablet (Drug)
Midazolam and placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum observed concentration of midazolam in plasma (Cmax)
时间窗: up to 24 hours after start of drug administration
Area under the concentration-time curve of midazolam from zero time extrapolated to infinity (AUC0-infinity)
时间窗: up to 24 hours after start of drug administration
次要结局
- Area under the concentration-time curve (AUC)(up to 24 hours after start of drug administration)
- Time to maximum observed concentration (tmax)(up to 24 hours after start of drug administration)
- Volume of distribution (V)(up to 24 hours after start of drug administration)
- Number of patients with clinically relevant findings in 12-lead ECG(up to day 8 after drug administration)
- Global assessment of tolerability by the investigator on a 4-point rating scale(up to 192 hours after start of drug administration)
- Terminal rate constant in plasma (λz)(up to 24 hours after start of drug administration)
- Individual time courses of plasma concentrations(up to 24 hours after start of drug administration)
- Changes from baseline in physical examination(pre-dose and day 8 after drug administration)
- Terminal half-life in plasma (t1/2)(up to 24 hours after start of drug administration)
- Mean residence time in the body (MRT)(up to 24 hours after start of drug administration)
- Apparent clearance in plasma (CL/F)(up to 24 hours after start of drug administration)
- Number of patients with clinically relevant findings in vital signs(up to day 8 after drug administration)
- Number of patients with clinically relevant findings in laboratory tests(up to day 8 after drug administration)
- Number of patients with adverse events(up to day 8 after drug administration)
研究者
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