NCT02223507已完成1 期
A Single-blind, Placebo-controlled Single Dose Tolerance Study in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 75 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 40 mg/h and 75 mg/h, Infusion Time 5 Hours)
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
- 13
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
The objective of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two increasing doses in healthy elderly volunteers, following the infusion schema of a loading dose (1 hour) and a maintenance dose (5 hours)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers
- •Age >= 60 years
- •Broca index from -25% to +25%
- •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 Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (exclusion: substitution therapy regarding thyroid gland and/or ovaries)
- •Diseases of the central nervous system (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders and medical history of such diseases or disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •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
- •Intake of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial)
- •Participation in another trial with an investigational drug (<= 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 (> 30g/day for males, > 24 g for females)
- •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
BIIR 561 CL
Experimental
干预措施: BIIR 561 CL (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: up to 8 days after drug administration
Number of subjects with clinically significant findings in vital functions
时间窗: up to 8 days after drug administration
blood pressure, pulse rate, respiratory rate, oral body temperature
Number of subjects with clinically significant findings in ECG
时间窗: up to 8 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
时间窗: up to 8 days after drug administration
次要结局
- Mean residence time (MRT)(up to 32 hours after first drug administration)
- Plasma clearance (CL)(up to 32 hours after first drug administration)
- Volume of distribution (Vz)(up to 32 hours after first drug administration)
- Volume of distribution at steady state (Vss)(up to 32 hours after first drug administration)
- Maximum drug plasma concentration (Cmax)(up to 32 hours after first drug administration)
- Time to Cmax (tmax)(up to 32 hours after first drug administration)
- Terminal half-life (t1/2)(up to 32 hours after first drug administration)
- Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)(up to 32 hours after first drug administration)
- Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)(up to 32 hours after first drug administration)
- Amount excreted into urine (Ae)(up to 32 hours after first drug administration)
研究者
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