NCT02261129已完成1 期
Bioequivalence of the 80 mg Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional 40 mg Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-sequence, 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
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable data point (AUC0-tz)
研究概览
简要总结
Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two tablets of the telmisartan 40 mg conventional tablet
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, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests
- •1.1 No findings deviating from normal and of clinical relevance
- •1.2 No evidence of a clinically relevant concomitant disease
- •Age ≥20 and ≤35 years
- •Body weight≥50kg
- •Body Mass Index ≥18.0 and ≤25.0 kg/m2
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
- •Any evidence of a clinically relevant concomitant disease
- •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
- •History of relevant allergy/hypersensitivity (including allergy to a drug or its excipients)
- •Any clinical relevant findings of the laboratory test deviating from normal
- •Positive result for either hepatitis B antigen, anti hepatitis C virus 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) varies by ≥20 mmHg from mean supine SBP 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 telmisartan formulation, or to any other angiotensin II receptor blockers
- •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 of the investigational product
- •Use of any drugs within 10 days before administration of the investigational product or during the trial
- •Participation in another trial with an investigational drug within four months before administration of the investigational product or during the trial
- •Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- •Alcohol abuse
- •Blood donation (100 mL or more) within four weeks before administration of the investigational product
- •Excessive physical activities within one week before administration of the investigational product 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
- •Any other clinical conditions that investigator or sub-investigator judges that the subject is ineligible for study participation
研究组 & 干预措施
Telmisartan, film-coated tablet
Experimental
one tablet of telmisartan
干预措施: Telmisartan film-coated tablet (Drug)
Telmisartan, conventional tablet
Active Comparator
Two tablets of telmisartan
干预措施: Telmisartan uncoated tablet (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable data point (AUC0-tz)
时间窗: up to 72 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to 72 hours after drug administration
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to 72 hours after drug administration)
- Time from dosing to the maximum measured concentration of the analyte in plasma (tmax)(up to 72 hours after drug administration)
- Terminal rate constant of the analyte in plasma (λz)(up to 72 hours after drug administration)
- Terminal half-life of the analyte in plasma (t1/2)(up to 72 hours after drug administration)
- mean residence time of the analyte in the body after po administration (MRTpo)(up to 72 hours after drug administration)
- Number of subjects with adverse events(up to 72 hours after last drug administration)
研究者
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