NCT02194309已完成1 期
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine (Free Dose Combination) in Healthy Male Volunteers
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
- 24
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers according to the following criteria:
- •No finding deviating of clinical relevance and no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests
- •Age ≥20 and Age ≤35 years
- •Body weight ≥50 kg
- •Body mass index (BMI) ≥17.6 and BMI ≤26.4 kg/m2
- •Signed and dated written informed consent before admission to the trial
排除标准
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Chronic or relevant acute infections
- •Any clinical relevant findings of the laboratory test deviating from normal
- •Positive result for either hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
- •History of surgery of gastrointestinal tract (except appendectomy)
- •History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varied by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varied by ≥10 mmHg from mean supine DBP), fainting spells or blackouts
- •History of hepatic dysfunction (e.g., biliary cirrhosis, cholestasis)
- •History of serious renal dysfunction
- •History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
- •History of cerebrovascular disorder
- •History of hyperkalemia
- •Known hypersensitivity to any component of the formulation, or to any other Angiotensin Receptor Blocker (ARB), angiotensin converting enzyme or dihydropyridine
- •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 before administration or during the trial
- •Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days before administration or during the trial
- •Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug before administration
- •Smoker (≥20 cigarettes/day)
- •Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
- •Blood donation (more than 100 mL within 4 weeks before administration or during the trial)
- •Excessive physical activities (within 1 week before administration or during the trial)
- •Intake of alcohol within 2 days before administration
- •Inability to comply with dietary regimen of trial centre
- •Intake of any drugs/supplements with ingredient of hypericum perforatum (citrus fruits, Sevilla orange) within 5 days prior to administration
- •Inability to refrain from smoking on trial days
研究组 & 干预措施
Telmisartan low + amlodipine
Experimental
干预措施: Telmisartan low (Drug)
Telmisartan low + amlodipine
Experimental
干预措施: amlodipine (Drug)
Telmisartan high + amlodipine
Experimental
干预措施: Telmisartan high (Drug)
Telmisartan high + amlodipine
Experimental
干预措施: amlodipine (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: up to 6 days after last administration in multiple dose phase
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
时间窗: up to 6 days after last administration in multiple dose phase
Assessment of tolerability by investigator on a four-point scale
时间窗: up to 6 days after last administration in multiple dose phase
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate, body temperature)
时间窗: up to 6 days after last administration in multiple dose phase
Number of patients with clinically significant changes in laboratory parameters
时间窗: up to 6 days after last administration in multiple dose phase
次要结局
- Predose concentration (Cpre) for several time points(up to day 10)
- Accumulation ratio (RA) based on Cmax(up to day 16)
- MRTpo (mean residence time of the analyte in the body after oral administration) for several time points(up to day 16)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration) for several time points(up to day 16)
- RA based on AUC(up to day 16)
- Cmax (maximum measured concentration of the analyte in plasma) for several time points(up to day 16)
- tmax (time from dosing to the maximum measured concentration of the analyte in plasma) for several time points(up to day 16)
- AUC (area under the concentration-time curve of the analyte in plasma) for several time points(up to day 16)
- λz (terminal rate constant in plasma) for several time points(up to day 16)
- t1/2 (terminal half-life of the analyte in plasma) for several time points(up to day 16)
- CL/F (apparent clearance of the analyte in plasma following extravascular administration) for several time points(up to day 16)
- C24,10(24 hours after last administration on day 10)
- Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)(up to day 16)
研究者
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