NCT02215005已完成1 期
Steady State Pharmacokinetics of 80 mg Telmisartan (Micardis®), 10 mg Ramipril (Delix®) or the Combination Following Repeated Oral Doses to Healthy Male and Female Volunteers (an Open-label, Randomised, Multiple-dose, Three-way Crossover Study)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- AUCτ,ss (area under the concentration-time curve in plasma at steady state over a uniform dosing interval τ)
研究概览
简要总结
The main objective was to investigate the effect of concurrent dosing of 10 mg ramipril and 80 mg telmisartan on the multiple-dose pharmacokinetics of telmisartan and ramipril. Therefore the relative bioavailability of telmisartan and ramipril given in combination was determined in comparison with either telmisartan or ramipril given alone.
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 55 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 (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- •Age ≥18 and ≤55 years
- •Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2
- •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 (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or inhibitors like cimetidine) or drugs that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration of trial drug 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)
- •Alcohol abuse (more than 60 g/day) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks prior to administration of trial drug or during the trial)
- •Excessive physical activities (within one week prior to administration of trial drug 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
- •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- •A history of additional risk factors for torsade de pointes (e.g., heart failure, hyperkalaemia, hypokalemia, family history of Long QT Syndrome)
- •Any history of relevant low blood pressure
- •Supine blood pressure at screening of systolic <110 mm Hg and diastolic <60 mm Hg
- •History of urticaria
- •History of angioneurotic edema
- •Hereditary fructose intolerance
- •Salt and/or volume depletion
- •For female subjects:
- •Pregnancy or planning to become pregnant during the study or within 1 months of study completion
- •Positive pregnancy test
- •Not willing or unable to use a reliable method of contraception such as implants, injectables, combined oral contraceptives, sterilisation, intrauterine device, double barrier method, sexual abstinence for at least 1 month, or vasectomised partner as only method of contraception for at least 6 months prior to participation in the trial, during and up to 1 month after completion/termination of the trial
- •Chronic use of oral contraception containing ethinyl estradiol as the only method of contraception
- •Currently lactating
研究组 & 干预措施
Telmisartan + Ramipril
Experimental
5 days qd
干预措施: Telmisartan (Drug)
Telmisartan + Ramipril
Experimental
5 days qd
干预措施: Ramipril (Drug)
Telmisartan
Active Comparator
5 days qd
干预措施: Telmisartan (Drug)
Ramipril
Active Comparator
5 days qd
干预措施: Ramipril (Drug)
结局指标
主要结局
AUCτ,ss (area under the concentration-time curve in plasma at steady state over a uniform dosing interval τ)
时间窗: up to 72 hours after last drug administration of each treatment
Cmax,ss (maximum measured concentration in plasma at steady state over a uniform dosing interval τ)
时间窗: up to 72 hours after last drug administration of each treatment
次要结局
- Concentration of the analytes in plasma(2, 4, and 12 hours after administration of the first dose of each treatment on day 1)
- pre-dose concentration of the analytes in plasma immediately before the administration of the next dose(pre-dose up to day 5 of each treatment)
- tmax,ss (time from last dosing to the maximum concentration of the analytes in plasma at steady state)(up to 72 hours after last drug administration of each treatment)
- Cmin,ss (minimum concentration of the analytes in plasma at steady state over a uniform dosing interval τ)(up to 72 hours after last drug administration of each treatment)
- Cpre,ss (pre-dose concentration of the analytes in plasma immediately before the administration of the next dose at steady state)(pre-dose up to day 5 of each treatment)
- Cavg (average concentration of the analytes in plasma at steady state)(up to 72 hours after last drug administration of each treatment)
- λz,ss (terminal rate constant in plasma at steady state)(up to 72 hours after last drug administration of each treatment)
- t1/2, ss (terminal half-life of the analyte in plasma at steady state)(up to 72 hours after last drug administration of each treatment)
- MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)(up to 72 hours after last drug administration of each treatment)
- CL/F,ss (apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration)(up to 72 hours after last drug administration of each treatment)
- Vz/F,ss (apparent volume of distribution of the analyte in plasma at steady state after extravascular multiple dose administration)(up to 72 hours after last drug administration of each treatment)
- PTF (Peak-Trough Fluctuation)(up to 72 hours after last drug administration of each treatment)
- AUC0-tz,ss (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(up to 72 hours after last drug administration of each treatment)
- Number of patients with adverse events(up to day 76)
- Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse rate)(up to day 76)
- Number of patients with clinically relevant changes in 12-lead electrocardiogram(up to day 76)
- Number of patients with clinically relevant changes in laboratory tests(up to day 76)
- Assessment of tolerability by the investigator on a 4-point scale(Day 8 of each treatment)
研究者
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