Influence of Food on the Bioavailability of Telmisartan 40 mg/Amlodipine 5 mg Fixed-dose Combination and of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination in Healthy Japanese Male Volunteers (a Phase I, Open-label, Randomised, Single-dose, Two-way Crossover Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- 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 (AUC0-tz)
研究概览
简要总结
Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) in the fed condition compared with those of the same fixed-dose combination in the fasting condition in healthy Japanese male volunteers.
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 male volunteers without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
- •Age: ≥20 and Age ≤35 years
- •Body weight: ≥50 kg
- •Body mass index (BMI): ≥18.0 and ≤25.0 kg/m2
- •Signed and dated written informed consent prior to admission to the trial in accordance with the 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 or neurological disorders
- •Chronic or relevant acute infections
- •Any clinical relevant findings in laboratory test results deviating from normal
- •A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilitic test, or an human immunodeficiency virus (HIV) test
- •History of surgery of the gastrointestinal tract (except appendectomy)
- •History of relevant orthostatic hypotension, fainting spells, or blackouts
- •Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin II receptor blockers, or to any other dihydropyridine compound
- •Intake of drugs with a long half-life (≥24 hours) within at least 1 month or less than 10 half-lives of the respective drug before drug administration
- •Intake of drugs which might reasonably influence the results of the trial on the basis of the knowledge at the time of protocol preparation within 7 days before drug administration
- •Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational products before drug administration
- •Smoker (≥20 cigarettes/day)
- •Alcohol abuse (60 g or more ethanol/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake)
- •Blood donation (more than 100 mL within 4 weeks before drug administration)
- •Excessive physical activities (within 1 week before drug administration)
- •Intake of alcohol within 2 days before drug administration
- •Inability to comply with dietary regimen of the study centre
- •Inability to refrain from smoking during trial days
- •Subjects judged to be inappropriate by the investigator or a sub-investigator
研究组 & 干预措施
Telmisartan/Amlodipine low dose, fed
Telmisartan low dose/Amlodipine fixed-dose combination
干预措施: Telmisartan/Amlodipine low dose (Drug)
Telmisartan/Amlodipine low dose, fed
Telmisartan low dose/Amlodipine fixed-dose combination
干预措施: Japanese meal (Other)
Telmisartan/Amlodipine low dose, fasted
Telmisartan low dose/Amlodipine fixed-dose combination
干预措施: Telmisartan/Amlodipine low dose (Drug)
Telmisartan/Amlodipine high dose, fed
Telmisartan high dose/Amlodipine fixed-dose combination
干预措施: Telmisartan/Amlodipine high dose (Drug)
Telmisartan/Amlodipine high dose, fed
Telmisartan high dose/Amlodipine fixed-dose combination
干预措施: Japanese meal (Other)
Telmisartan/Amlodipine high dose, fasted
Telmisartan high dose/Amlodipine fixed-dose combination
干预措施: Telmisartan/Amlodipine high dose (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 the time of the last quantifiable data point (AUC0-tz)
时间窗: up to 144 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to 144 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 144 hours after drug administration)
- Time from dosing to the maximum concentration of the analyte in plasma (tmax)(up to 144 hours after drug administration)
- Terminal rate constant of the analyte in plasma (λz)(up to 144 hours after drug administration)
- Terminal half-life of the analyte in plasma (t1/2)(up to 144 hours after drug administration)
- Mean residence time of the analyte in the body after po administration (MRTpo)(up to 144 hours after drug administration)
- Number of subjects with adverse events(up to 56 days)