NCT02187536已完成1 期
Pharmacokinetics of Single Oral Doses of 40 mg Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan 80 mg Daily, Given Orally Over 6 Days. A Randomised, Placebo Controlled, Double Blind (for Telmisartan), Two Way Cross Over Trial in 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
- 16
- 主要终点
- Area under the concentration-time curve of simvastatin and simvastatin acid in plasma at different time points (AUC)
研究概览
简要总结
To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan
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
- Double
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 subjects as determined by results of screening
- •Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- •Age ≥ 18 and ≤ 55 years
- •Broca ≥ -20 % and ≤ +20 %
排除标准
- •Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of the gastro-intestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infection
- •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 (30 days prior to administration or during the trial)
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (≤ 1 month prior to administration or during the trial)
- •Excessive physical activities (≤ 5 days prior to administration or during the trial)
- •Any laboratory value outside the reference range of clinical relevance
- •Hypersensitivity to telmisartan and/or simvastatin and/or related classes of drugs
- •For female subjects:
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception (e.g. sterilization, intrauterine device (IUD), oral contraceptives)
- •Inability to maintain this adequate contraception during the whole study period
- •Lactation period
研究组 & 干预措施
Telmisartan combined with Simvastatin
Experimental
Telmisartan once daily (day 1 to day 6) and Simvastatin given once (day 6)
干预措施: Telmisartan (Drug)
Telmisartan combined with Simvastatin
Experimental
Telmisartan once daily (day 1 to day 6) and Simvastatin given once (day 6)
干预措施: Simvastatin (Drug)
Simvastatin and telmisartan placebo
Active Comparator
Telmisartan placebo once daily (day 1 to day 6) and Simvastatin given once (day 6)
干预措施: Simvastatin (Drug)
Simvastatin and telmisartan placebo
Active Comparator
Telmisartan placebo once daily (day 1 to day 6) and Simvastatin given once (day 6)
干预措施: Telmisartan placebo (Drug)
结局指标
主要结局
Area under the concentration-time curve of simvastatin and simvastatin acid in plasma at different time points (AUC)
时间窗: Pre-dose, up to day 32 after start of treatment
Maximum concentration of simvastatin and simvastatin acid in plasma (Cmax)
时间窗: Pre-dose, up to day 32 after start of treatment
次要结局
- Time to Cmax after a single extravascular dose (tmax)(Pre-dose, up to day 32 after start of treatment)
- Apparent volume of distribution during the terminal phase (Vz/f)(Pre-dose, up to day 32 after start of treatment)
- Maximum concentration of telmisartan in plasma at steady state (Cmax,ss)(Pre-dose, up to day 32 after start of treatment)
- Number of patients with clinically relevant findings in laboratory values(Pre-dose, up to day 32 after start of treatment)
- Area under the plasma concentration-time curve of telmisartan at steady state (AUCss)(Pre-dose, up to day 32 after start of treatment)
- Elimination half-life in plasma (t1/2)(Pre-dose, up to day 32 after start of treatment)
- Total clearance from plasma (CLtot/f)(Pre-dose, up to day 32 after start of treatment)
- Mean time of residence in the body (MRTtot)(Pre-dose, up to day 32 after start of treatment)
- Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)(Pre-dose, up to day 32 after start of treatment)
- Number of patients with adverse events(Up to day 32 after start of treatment)
- Number of patients with clinically relevant findings in ECG(Pre-dose, up to day 32 after start of treatment)
研究者
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