Tolerability and Pharmacokinetics of 80 mg Telmisartan and 6 mg Lacidipine Alone and in Combination After 7 Days Treatment. An Open Randomised Three-way Cross-over Trial in Female and Male Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Cmax (Maximum measured concentration of the analyte in plasma)
研究概览
简要总结
The objectives of this study are to compare the steady state pharmacokinetics of lacidipine with and without the co-administration of telmisartan and to compare the steady state pharmacokinetics of telmisartan with and without the co-administration of lacidipine
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%
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)
- •Any laboratory value outside the reference range of clinical relevance
- •Female only:
- •no reliable contraception (reliable are: oral contraceptives, 3-month injection, Intrauterine devices (IUD), sterilization)
- •Pregnancy or breast feeding period
研究组 & 干预措施
Lacidipine
干预措施: Lacidipine (Drug)
Telmisartan
干预措施: Telmisartan (Drug)
Lacidipine + Telmisartan
干预措施: Lacidipine (Drug)
Lacidipine + Telmisartan
干预措施: Telmisartan (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
Cmin (Minimum measured concentration of the analyte in plasma)
时间窗: up to 72 hours after drug administration
Number of subjects with clinically significant changes in vital signs
时间窗: up to 12 days after last drug administration
Number of subjects with abnormal changes in laboratory parameters
时间窗: up to 12 days after last drug administration
AUCss (Area under the concentration-time curve of the analyte in plasma at steady state)
时间窗: up to 72 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
时间窗: up to 72 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
时间窗: up to 72 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration) )
时间窗: up to 72 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
时间窗: up to 72 hours after drug administration
MRT (Mean residence time of the analyte in the body)
时间窗: up to 72 hours after drug administration
Number of subjects with adverse events
时间窗: up to 66 days
次要结局
未报告次要终点