NCT02262780已完成1 期
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (40 mg Telmisartan / 12.5 mg HCTZ to 80 mg Telmisartan / 12.5 mg HCTZ) and Multiple Oral Doses (80 mg Telmisartan / 12.5 mg HCTZ) of Drug 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
- 20
- 主要终点
- Global assessment of tolerability by the investigator
研究概览
简要总结
Group 1:
To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and T80/H12.5)
Group 2:
To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7 days)
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 males 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 (BP), pulse rate (PR), body temperature), 12-lead ECG, clinical laboratory tests
- •Age ≥20 and Age ≤35 years
- •Body Mass Index (BMI) ≥17.6 and BMI ≤26.4 kg/m2
- •Signed and dated written informed consent prior to admission to the study in accordance with "Good Clinical Practice (GCP)"
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 laboratory value outside the reference range that is of clinical relevance
- •Positive result for hepatitis B surface (HBs) antigen, anti hepatitis C virus (HCV) antibodies, Syphilitic test or HIV test
- •Surgery of gastrointestinal tract (except appendectomy)
- •History of relevant orthostatic hypotension (mean standing SBP varies by ≥ 20 mmHg from mean supine systolic blood pressure (SBP) and/or mean standing diastolic blood pressure (DBP) varies 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; known hypersensitivity to any other angiotensin II receptor antagonist; known hypersensitivity to sulfonamides or sulphonamide-derived drugs (e.g. thiazides)
- •History of impaired glucose tolerance
- •History of hypokalemia
- •History of hyperuricemia
- •Salt restriction therapy
- •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 based on the knowledge at the time of protocol preparation within 7 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within four months or 6 half-lives of the investigational drug, whichever is longer, prior to administration or during the trial
- •Smoker (more than 20 cigarettes /day)
- •Alcohol abuse
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- •Excessive physical activities (within seven days prior to administration)
- •Intake of alcohol within two days prior to administration
- •Inability to comply with dietary regimen of study centre
- •Inability to comply with smoking cessation during hospitalization
研究组 & 干预措施
Single low dose Telmisartan with HCTZ
Experimental
干预措施: Low dose of telmisartan (Drug)
Single low dose Telmisartan with HCTZ
Experimental
干预措施: HCTZ (Drug)
Single high dose Telmisartan with HCTZ
Experimental
干预措施: High dose of telmisartan (Drug)
Single high dose Telmisartan with HCTZ
Experimental
干预措施: HCTZ (Drug)
Multiple high dose Telmisartan with HCTZ
Experimental
干预措施: High dose of telmisartan (Drug)
Multiple high dose Telmisartan with HCTZ
Experimental
干预措施: HCTZ (Drug)
结局指标
主要结局
Global assessment of tolerability by the investigator
时间窗: up to 10 days after last drug administration
verbal rating scale
Number of patients with clinically relevant findings in clinical laboratory tests
时间窗: up to 10 days after last drug administration
Number of patients with adverse events
时间窗: up to 10 days after last drug administration
Number of patients with clinically relevant findings in physical examination
时间窗: up to 10 days after last drug administration
Number of patients with clinically relevant findings in vital signs
时间窗: up to 10 days after last drug administration
blood pressure, pulse rate, body temperature
Number of patients with clinically relevant findings in 12-lead ECG
时间窗: up to 10 days after last drug administration
次要结局
- Maximum concentration of the analytes in plasma (Cmax)(Up to 96 hours after drug administration)
- Mean residence time of the analytes in the body after po administration (MRTpo)(Up to 96 hours after drug administration)
- Apparent volume of distribution of the analytes in plasma during the terminal phase λz following an extravascular dose (Vz/F)(Up to 96 hours after drug administration)
- Amount of HCTZ that is eliminated in urine from the time interval t1 to t2 (Aet1-t2)(Up to 48 hours after drug administration)
- Renal clearance of HCTZ in plasma from the time point t1 until the time point t2 (CLR, t1-t2)(Up to 48 hours after drug administration)
- Average concentration of the analytes in plasma at steady state (Cavg)(Up to 96 hours after drug administration)
- Terminal rate constant of the analytes in plasma (λz)(Up to 96 hours after drug administration)
- Fraction of HCTZ excreted unchanged in urine from time point t1 to t2 (fet1-t2)(Up to 48 hours after drug administration)
- Terminal half-life of the analytes in plasma (t1/2)(Up to 96 hours after drug administration)
- Area under the concentration time curve of the analytes in plasma (AUC)(Up to 96 hours after drug administration)
- Time from dosing to maximum concentration of the analytes in plasma (tmax)(Up to 96 hours after drug administration)
- Apparent clearance of the analytes in the plasma after extravascular administration (CL/F)(Up to 96 hours after drug administration)
- Accumulation ratio of the analytes in plasma after multiple dose administration over a uniform dosing interval τ (RA)(Up to 96 hours after drug administration)
- Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)(Up to 96 hours after drug administration)
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