Administration of ESR 1150 CL in Ascending Doses of 0.5, 1, 2, 4 and 8 mg in an Open, Group Comparison and Placebo-controlled Design (Placebo Randomised Double Blind in the Dose Groups) for the Assessment of Safety, Tolerability (Maximum Tolerated Dose, MTD), Pharmacokinetics and Pharmacodynamics in 5 Groups of 8 Female and 5 Male Healthy Subjects, and 4 mg Additionally in Fed State, in a Cross Over Design. Safety, Tolerability and Pharmacokinetics of MTD/4, MTD/2 and MTD in 6 Healthy Male Subjects, Identified as CYP2D6 and/or "Spartein" Poor Metabolizers, in a 3-fold Cross Over, Open Study.

Boehringer Ingelheim0 个研究点目标入组 39 人开始时间: 2000年2月最近更新: 2014年8月6日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: Boehringer Ingelheim
入组人数: 39
主要终点: Maximum flow rate (Qmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of this study was to obtain safety and tolerability data and first pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL.

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: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male and female Caucasian subjects as determined by results of screening
•Written informed consent in accordance with Good Clinical Practice and local legislation given
•Age ≥ 18 and ≤ 50 years
•Broca ≥ - 20 % and ≤ + 20 %
•for first part of study: extensive metabolizers of CYP2D6 and/or "spartein" type; for second part of study: poor metabolizers of CYP2D6 and/or "spartein"

排除标准

•Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
•Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
•Surgery of gastrointestinal tract (except appendectomy)
•Diseases of the central nervous system (such as epilepsy) or psychiatric disorders of neurological disorders
•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) (≤ 1 month prior to administration or during the trial, except for oral contraceptives)
•Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial except for oral contraceptives)
•Participation in another trial with an investigational drug (≤ 2 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/days)
•Drug abuse
•Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial)
•Excessive physical activities (≤ 10 days prior to administration or during the trial)
•Any laboratory value outside the reference range of clinical relevance
•Females only:
•No reliable contraception (examples of reliable contraception: oral contraceptives, 3-month injection, intrauterine device, sterilisation, condoms + spermicide)
•pregnancy or breast feeding period

研究组 & 干预措施

ESR 1150 CL dose escalation fasted

Experimental

干预措施: ESR 1150 CL (Drug)

ESR 1150 CL fed

Experimental

干预措施: ESR 1150 CL (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)