NCT02187523已完成1 期
Relative Oral Bioavailability of 40 mg Telmisartan / 12.5 mg HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Subjects. A 4 Period Cross-over, Open, Randomized, Replicate 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
- 32
- 主要终点
- Total area under concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)
研究概览
简要总结
A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations
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 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 electrocardiogram (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 or 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 (≤ 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 HCTZ 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/HCTZ FDC
Experimental
干预措施: Telmisartan/HCTZ FDC (Drug)
Telmisartan and HCTZ individual tablets
Active Comparator
干预措施: Hydrochlorothiazide (Drug)
Telmisartan and HCTZ individual tablets
Active Comparator
干预措施: Telmisartan (Drug)
结局指标
主要结局
Total area under concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)
时间窗: Pre-dose up to day 54
Maximum concentration of the analytes in plasma (Cmax)
时间窗: Pre-dose up to day 54
Amount of HCTZ excreted in urine over 48 h (Ae(0-48))
时间窗: Pre-dose up to day 50
次要结局
- time to achieve maximum concentration of the analytes in plasma (tmax)(Pre-dose up to day 54)
- Terminal elimination half life of the analytes in plasma (t1/2)(Pre-dose up to day 54)
- Total clearance of the of the analytes after oral administration (CLtot/f)(Pre-dose up to day 54)
- Total mean residence time of the analytes (MRTtot)(Pre-dose up to day 54)
- Apparent volume of distribution of the analytes during the terminal phase (Vz/f)(Pre-dose up to day 54)
- Number of patients with relevant changes in laboratory values(Screening (day -14 to day 0) and day 72)
- Number of patients with relevant changes in vital signs (blood pressure, pulse rate)(Up to day 72)
- Number of patients with Adverse events(Up to day 72)
- Number of patients with relevant changes in ECG(Screening (day -14 to day 0) and day 72)
- Number of patients with relevant changes in physical examination(Screening (day -14 to day 0) and day 72)
研究者
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