NCT02176512已完成1 期
Relative Oral Bioavailability of 80 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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- AUC0-∞ (total area under the plasma drug concentration-time curve from time zero to infinity)
研究概览
简要总结
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 45 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 GCP (Good Clinical Practice) and local legislation
- •Age ≥ 18 and ≤ 45 years
- •Broca ≥ - 20% and ≤ + 20%
排除标准
- •Any findings of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) 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
- •Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
- •History of orthostatic hypotension, fainting spells or blackouts
- •Hypersensitivity to Telmisartan and/or HCTZ and/or related classes of drugs
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •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
- •Known alcohol abuse
- •Known drug abuse
- •Blood donation (≤ 1 month prior to administration)
- •Excessive physical activities (≤ 5 days prior to administration)
- •For female subjects:
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception
- •Inability to maintain this adequate contraception during the whole study period
- •Lactation period
研究组 & 干预措施
Sequence 1
Experimental
four treatment periods:
- Treatment A
- Treatment B
- Treatment B
- Treatment A
干预措施: BIBR 277 SE and HCTZ (Drug)
Sequence 1
Experimental
four treatment periods:
- Treatment A
- Treatment B
- Treatment B
- Treatment A
干预措施: BIBR 277 SE (Drug)
Sequence 1
Experimental
four treatment periods:
- Treatment A
- Treatment B
- Treatment B
- Treatment A
干预措施: HCTZ (Drug)
Sequence 2
Active Comparator
four treatment periods:
- Treatment B
- Treatment A
- Treatment A
- Treatment B
干预措施: BIBR 277 SE and HCTZ (Drug)
Sequence 2
Active Comparator
four treatment periods:
- Treatment B
- Treatment A
- Treatment A
- Treatment B
干预措施: BIBR 277 SE (Drug)
Sequence 2
Active Comparator
four treatment periods:
- Treatment B
- Treatment A
- Treatment A
- Treatment B
干预措施: HCTZ (Drug)
结局指标
主要结局
AUC0-∞ (total area under the plasma drug concentration-time curve from time zero to infinity)
时间窗: up to 96 hours post-dose
Cmax (maximum drug plasma concentration)
时间窗: up to 96 hours post-dose
Amount of Hydrochlorothiazide (HCTZ) excreted in urine over 48 hours (Ae(0-48h))
时间窗: 0-6, 6-12, 12-24, 24-32, 32-48 hours post-dose
次要结局
- t1/2 (apparent terminal elimination half-life)(up to 96 hours post-dose)
- CLtot/f (total clearance of a drug from plasma, divided by bioavailability)(up to 96 hours post-dose)
- MRTtot (mean time of residence of drug molecules in the body)(up to 96 hours post-dose)
- tmax (time to achieve Cmax)(up to 96 hours post-dose)
- Vz/f (apparent volume of distribution during terminal phase)(up to 96 hours post-dose)
- Number of patients with adverse events(Up to 62 days)
研究者
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