NCT02193308已完成1 期
Bioequivalence of 80 mg Telmisartan / 10 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, Two Sequence, Two-period 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
- 84
- 主要终点
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
研究概览
简要总结
To demonstrate the bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose combination (FDC) 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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females according to the following criteria:
- •Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- •Age ≥18 and ≤55 years
- •BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- •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 BP, PR 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
- •Surgery of the 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- •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 (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or inhibitors like cimetidine) or that prolong the QT/QTc interval 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 two months prior to administration or during the trial
- •Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- •Inability to refrain from smoking during 24 hours prior to dosing and during the trial
- •Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing and during the trial
- •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 trial site
- •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- •A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hyperkalemia, hypokalemia, family history of Long QT Syndrome)
- •Any history of relevant low blood pressure
- •Supine blood pressure at screening of systolic <110 mm Hg and diastolic <60 mm Hg
- •History of urticaria
- •History of angioneurotic edema
- •Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
- •No adequate contraception during the study and until 1 month of study completion, i.e. implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who have not a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
- •Lactation period
研究组 & 干预措施
Telmisartan/Amlodipine FDC
Experimental
干预措施: Telmisartan/Amlodipine FDC (Drug)
Telmisartan + Amlodipine mono
Active Comparator
干预措施: Telmisartan (Drug)
Telmisartan + Amlodipine mono
Active Comparator
干预措施: Amlodipine (Drug)
结局指标
主要结局
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
时间窗: up to 168 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: up to 168 hours after drug administration
次要结局
- t1/2 (terminal half-life of the analyte in plasma)(up to 168 hours after drug administration)
- MRTpo (mean residence time of the analyte in the body after oral administration)(up to 168 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz after oral administration)(up to 168 hours after drug administration)
- Number of patients with adverse events(up to 65 days)
- 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)(up to 168 hours after drug administration)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(up to 168 hours after drug administration)
- λz (terminal rate constant in plasma)(up to 168 hours after drug administration)
- Assessment of tolerability by investigator on a 4-point scale(Day 8 of each trial period)
- CL/F (apparent clearance of the analyte in plasma after oral administration)(up to 168 hours after drug administration)
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