NCT02276391已完成1 期
Bioequivalence of Telmisartan Administrated in Two Different Ways: Either in Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination Tablet or as Two Telmisartan 40 mg Tablets (an Open-label, Randomised, Single-dose, Four-period Replicated Crossover 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
- 64
- 主要终点
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
研究概览
简要总结
To establish bioequivalence of telmisartan orally administrated in two different ways: either with a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination tablet or with two telmisartan 40 mg tablets
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
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese males according to the following criteria:
- •Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG (electrocardiogram), clinical laboratory tests
- •Age ≥20 and Age ≤35 years
- •Body weight ≥50 kg
- •Body Mass Index (BMI) ≥18.0 and BMI ≤25.0 kg/m2
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
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 (HBs) antigen, 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, fainting spells or blackouts
- •Known hypersensitivity to any component of the formulation (telmisartan and hydrochlorothiazide), or to any other angiotensin II receptor blocker (ARBs), any other thiazides, or thiazide derivatives (e.c. sulfonamide derivatives like a chlorthalidone)
- •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
- •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 4 months or 6 half-lives of the investigational drug prior to 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 prior to administration or during the trial)
- •Excessive physical activities (within 1 week prior to administration or during the trial)
- •Intake of alcohol within 2 days prior to administration
- •Inability to comply with dietary regimen of study centre
- •Inability to refrain from smoking on trial days
- •Subjects judged to be inappropriate by the investigator or the sub-investigator
研究组 & 干预措施
Telmisartan/HCTZ fixed-dose combination
Experimental
干预措施: Telmisartan/HCTZ combination (Drug)
Telmisartan
Active Comparator
干预措施: Telmisartan (Drug)
结局指标
主要结局
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
时间窗: Up to 72 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: Up to 72 hours after drug administration
次要结局
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(Up to 72 hours after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(Up to 72 hours after drug administration)
- MRTpo (mean residence time of the analyte in the body after po administration)(Up to 72 hours after drug administration)
- tmax (time from dosing to the maximum measured concentration of the analyte in plasma)(Up to 72 hours after drug administration)
- Number of participants with clinically significant findings in physical examination(Up to 72 hours after last drug administration)
- Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram)(Up to 72 hours after last drug administration)
- Number of participants with adverse events(Up to 72 hours after last drug administration)
- Number of participants with clinically significant findings in vital signs(Up to 72 hours after last drug administration)
- Number of participants with clinically significant findings in clinical laboratory parameters(Up to 72 hours after last drug administration)
- λz (terminal rate constant of the analyte in plasma)(Up to 72 hours after drug administration)
研究者
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