NCT02262624已完成1 期
Bioequivalence of 80 mg Telmisartan/12.5 mg HCTZ of Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way 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
- 36
- 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 last quantifiable data point)
研究概览
简要总结
To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs. its monocomponents
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 males according to the following criteria:
- •Based upon a complete medical history, physical finding, physical examination (measurements of height and body weight), vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests 1) No finding of clinical relevance 2) No evidence of a clinically relevant concomitant disease
- •Age ≥ 20 years and age ≤ 35 years
- •Body Mass Index (BMI) ≥ 17.6 kg/m2 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) (MHW Ordinance No. 28, as of Mar. 27, 1997) and the local legislation
排除标准
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Positive result for Hepatitis B virus surface antigen (HBsAg), anti HCV (Hepatitis C virus), syphilitic test or Human immunodeficiency virus (HIV) antigen-antibody test
- •Intake of drugs with a long half-life (≥ 24 hours) within at least 1 month prior to administration or within a period of 10 or less half-lives of the respective drugs 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 10 days prior to administration or during the trial.
- •Participation in another trial with an investigational drug within 4 months prior to administration or during the trial
- •Smoker (20 or more cigarettes/day)
- •Inability to refrain from smoking during hospitalisation
- •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 four weeks prior to administration or during the trial)
- •Excessive physical activities (within one week prior to administration or during the trial)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of study centre
- •Any other volunteers whom, the investigator or sub investigator would not allow to participate in this study
研究组 & 干预措施
Telmisartan/HCTZ fixed combination
Experimental
干预措施: Telmisartan/HCTZ fixed combination (Drug)
Telmisartan and HCTZ monocomponents
Active Comparator
干预措施: Telmisartan (Drug)
Telmisartan and HCTZ monocomponents
Active Comparator
干预措施: Hydrochlorthiazide (HCTZ) (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 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
- Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram)(Up to 9 days after last drug administration)
- Number of participants with clinically significant findings in laboratory parameters(Up to 9 days after last drug administration)
- Number of participants with adverse events(Up to 9 days after last drug administration)
- 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)
- 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 concentration of the analyte in plasma)(Up to 72 hours after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(Up to 72 hours after drug administration)
- Number of participants with clinically significant findings in physical examination(Up to 9 days after last drug administration)
- Number of participants with clinically significant findings in vital signs(Up to 9 days 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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