NCT02259816已完成1 期
Pharmacokinetics of Repeated Oral Doses of 80 mg Telmisartan (Micardis®) at Steady State Alone and in Combination With Repeated Oral Doses of Amlodipine 10 mg (Norvasc®) at Steady State. A Two-way Crossover, Open, Randomised Design Study
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
- 38
- 主要终点
- Area under the concentration-time curve of telmisartan in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
研究概览
简要总结
Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in combination with repeated doses of 10 mg amlodipine
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 males and females according to the following criteria:
- •Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- •Age ≥18 and Age ≤50 years
- •BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
排除标准
- •Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- •Any evidence of a clinically relevant concomitant disease
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of the gastrointestinal tract (except appendectomy)
- •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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- •Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- •Use of drugs which might reasonably influence the results of the trial or that prolong the QT/corrected QT interval based on the knowledge at the time of protocol preparation within 10 days 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 (more than 60 g/day)
- •Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- •Excessive physical activities (within one week prior to administration or during the trial)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of trial site
- •Any history of relevant low blood pressure
- •Supine blood pressure at screening of systolic <110 mm Hg and/or diastolic <60 mm Hg
- •History of urticaria
- •For female subjects:
- •Pregnancy or planning to become pregnant within 2 months of study completion
- •Positive pregnancy test
- •No adequate contraception e.g. sterilisation, intrauterine device, have not been using a barrier method of contraception for at least 3 months prior to participation in the study
- •Are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial
- •Chronic use of oral contraception or hormone replacement containing ethinyl estradiol as the only method of contraception
- •Partner is unwilling to use condoms
- •Lactation period
研究组 & 干预措施
Telmisartan and amlodipine
Experimental
干预措施: Amlodipine (Drug)
Telmisartan and amlodipine
Experimental
干预措施: Telmisartan (Drug)
Telmisartan
Active Comparator
干预措施: Telmisartan (Drug)
结局指标
主要结局
Area under the concentration-time curve of telmisartan in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
时间窗: up to 15 days after first administration of study drug
Maximum measured concentration of telmisartan in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
时间窗: up to 15 days after first administration of study drug
次要结局
- Pre-dose concentration of the analyte in plasma immediately before the administration of the next dose N (Cpre,N)(pre-dose on days 2-9)
- Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)(up to 144 hours after last administration of study drug)
- AUCτ,ss for amlodipine(up to 15 days after first administration of study drug)
- Cmax,ss for amlodipine(up to 15 days after first administration of study drug)
- Maximum measured concentration of the analyte in plasma (Cmax)(up to 12 hours after first administration of study drug)
- Time from dosing to maximum measured concentration on plasma (tmax)(up to 12 hours after first administration of study drug)
- Area under the plasma concentration-time curve over a uniform dosing interval τ after administration of the first dose; corresponds to AUC0-24h (AUCτ,1)(up to 12 hours after first administration of study drug)
- Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)(up to 144 hours after last administration of study drug)
- Terminal rate constant in plasma at steady state (λz,ss)(up to 144 hours after last administration of study drug)
- Terminal half-life of the analyte in plasma at steady state (t1/2, ss)(up to 144 hours after last administration of study drug)
- Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)(up to 144 hours after last administration of study drug)
- Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)(up to 144 hours after last administration of study drug)
- Apparent volume of distribution of the analyte in plasma at steady state after extravascular multiple dose administration (Vz/F,ss)(up to 144 hours after last administration of study drug)
- Accumulation ratio of the analyte in plasma based on AUC over a uniform dosing interval after the first and last doses (RA, AUC)(up to 15 days after first administration of study drug)
- Accumulation ratio of the analyte in plasma based on Cmax over a uniform dosing interval after the last and first doses (RA,Cmax)(up to 15 days after first administration of study drug)
- Number of subjects with adverse events(up to 80 days)
- Assessment of tolerability by investigator on a 4-point scale(within 14 days after last trial procedure)
研究者
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