NCT02262585已完成1 期
Bioequivalence Study of BIBR 277 Tablet (Mannitol Based) Compared With Its Capsule Formation 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
- 30
- 主要终点
- Cmax (maximum observed concentration of the Telmisartan in plasma)
研究概览
简要总结
Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277 capsule
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
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 20 and <= 35 years
- •Weight: BMI > 17.6 and < 26.4 (Weight (kg) / Height (m)2)
- •Subjects judged by the investigator to be eligible as study subjects, with no clinically significant findings after screening
- •Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent
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
- •History of hepatic disorder (e.g., biliary cirrhosis, cholestasis)
- •History of serious renal disorder
- •History of or present bilateral renal artery stenosis or lack of unilateral kidney accompanying arterial stenosis
- •History of or present cerebrovascular disorder
- •History of hyperkalemia
- •History of hypersensitivity to active ingredient (Telmisartan) or other angiotensin II receptor antagonists
- •History of or present orthostatic hypotension or faint
- •Surgery of gastrointestinal tract (except appendectomy)
- •History of alcohol or drug abuse
- •Participation to another trial with an investigational drug within 4 months prior to the trial
- •Whole blood donation more than 400 mL within 3 months prior to the trial
- •Whole blood donation more than 100 mL within 1 month prior to the trial
- •Donation of constituent of blood of more than 400 mL within 1 month prior to the trial
- •Any medication which might influence the result of the trial within 10 days prior to the trial
- •Excessive physical activities within 7 days prior to the trial
- •Alcohol drinking within 3 days prior to the trial
- •Inability to comply with restriction of protocol
- •Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
研究组 & 干预措施
BIBR 277 tablet
Experimental
(Mannitol based)
干预措施: BIBR 277 tablet (Drug)
BIBR 277 capsule
Active Comparator
干预措施: BIBR 277 capsule (Drug)
结局指标
主要结局
Cmax (maximum observed concentration of the Telmisartan in plasma)
时间窗: up to 72 hours after drug administration
AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr
时间窗: up to 72 hours after drug administration
次要结局
- Individual time courses of the Telmisartan plasma concentrations(up to 72 hours after drug administration)
- tmax (time to reach Cmax)(up to 72 hours after drug administration)
- t1/2 (terminal half-life of the Telmisartan in plasma)(up to 72 hours after drug administration)
- AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity)(up to 72 hours after drug administration)
- MRT0-∞ (total mean residence time of Telmisartan molecules in the body)(up to 72 hours after drug administration)
- Number of subjects with adverse events(up to 72 hours after drug administration)
- Number of subjects with clinically significant findings in vital signs(up to 72 hours after drug administration)
- Number of subjects with clinically significant findings in ECG(up to 72 hours after drug administration)
- Number of subjects with clinically significant findings in laboratory tests(up to 72 hours after drug administration)
研究者
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