NCT02218684已完成1 期
Tolerability and Pharmacokinetics of 80 mg Telmisartan in Combination With 2, 4, or 6 mg Lacidipine. An Open, Single Rising Dose Group Comparison Trial - Placebo Randomised Double Blind in Each Dose Group - in Male Healthy 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
- 27
- 主要终点
- Cmax (Maximum measured concentration of the analyte in plasma)
研究概览
简要总结
The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male 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%
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
- •Surgery of gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic 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)
- •Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
- •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 study days
- •Alcohol abuse (> 60g/day)
- •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
研究组 & 干预措施
Telmisartan + Lacidipine - low dose
Experimental
干预措施: Lacidipine (Drug)
Telmisartan + Lacidipine - low dose
Experimental
干预措施: Telmisartan (Drug)
Telmisartan + Lacidipine - medium dose
Experimental
干预措施: Telmisartan (Drug)
Telmisartan + Lacidipine - medium dose
Experimental
干预措施: Lacidipine (Drug)
Telmisartan + Lacidipine - high dose
Experimental
干预措施: Telmisartan (Drug)
Telmisartan + Lacidipine - high dose
Experimental
干预措施: Lacidipine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Cmax (Maximum measured concentration of the analyte in plasma)
时间窗: up to 72 hours after drug administration
Number of subjects with adverse events
时间窗: up to 72 hours after drug administration
次要结局
- AUC (Area under the concentration-time curve of the analyte in plasma)(up to 72 hours after drug administration)
- tmax (Time from dosing to the maximum concentration of the analyte in plasma)(up to 72 hours after drug administration)
- CL/F (Apparent clearance of the analyte in plasma following extravascular administration)(up to 72 hours after drug administration)
- Vz/F (Apparent volume of distribution of the analyte during the terminal phase)(up to 72 hours after drug administration)
- MRT (Mean residence time of the analyte in the body)(up to 72 hours after drug administration)
- t½ (Terminal half-life of the analyte in plasma)(up to 72 hours after drug administration)
- Number of subjects with abnormal changes in laboratory parameters(up to 72 hours after drug administration)
- Number of subjects with clinically significant changes in vital signs(up to 72 hours after drug administration)
研究者
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