NCT02171468已完成1 期
Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule (110 mg and 150 mg b.i.d., 7 Days) in Healthy Japanese and Caucasian Male Subjects (Open Label 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
- 48
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
To investigate and compare pharmacokinetics, safety and pharmacodynamics of dabigatran etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days) in healthy male subjects between Japanese and Caucasians
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese or Caucasian healthy male subjects according to the following criteria:
- •Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead electrocardiogram, clinical laboratory tests
- •No finding of clinical relevance
- •No evidence of a clinically relevant concomitant disease
- •Caucasian subjects are from a well-defined Caucasian population, both parents of Caucasians, the subjects can understand the subject information for informed consent in English and the subjects have lived 8 or less than 8 years in Japan
- •Age: ≥20 and ≤45 years
- •Body mass index (BMI): ≥18.5 and ≤29.9 kg/m2
- •Signed and dated written informed consent before admission to the trial site
排除标准
- •Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Subject can not use an adequate form of contraception from the time of the first dose on Day 1 up to end-of study examination
- •Current diseases of the central nervous system (such as epilepsy), or psychiatric disorders or neurological disorders
- •History of clinically significant orthostatic hypotension, clinically significant current or past fainting spells or blackouts
- •Chronic or relevant acute infections
- •allergy/hypersensitivity (including drug allergy) which is deemed relevant to the safety assessment as judged by the investigator (excluding asymptomatic seasonal rhinitis/hay fever)
- •any bleeding disorder including prolonged or habitual bleeding
- •other hematologic diseases
- •cerebral bleeding (e.g. after a car accident)
- •concussions (head trauma resulting in injuring to brain) with or without loss of consciousness
- •Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives, whichever is shorter, of the respective drug prior to administration or during the trial
- •Use of aspirin (including over-the-counter medications), antipletelet agents like ticlopidine or dipyridamole, chronic administration of nonsteroidal antiinflammatory drugs , coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 28 days prior to administration up to end-of-study examination
- •Participation in another trial with an investigational drug within 3 months prior to administration up to end-of-study examination
- •Smoker (>10 cigarettes/day or inability to refrain from smoking during the trial)
- •Alcohol abuse (more than 60 g/day; confirmed by interview)
- •Drug abuse (confirmed by interview)
- •Blood donation (more than 100 mL from 3 months prior to screening and any blood donation from screening up to end-of-study examination)
- •Excessive physical activities (within 7 days prior to the first drug administration up to end-of-study examination)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Known hypersensitivity to the investigational drug or its excipients
- •Subject who was judged ineligible by the investigator or the sub-investigator
- •History of any familial bleeding disorder
- •Thrombocytes <15 x 10**4 /microL
研究组 & 干预措施
Dabigatran high dose
Experimental
干预措施: Dabigatran high dose (Drug)
Dabigatran low dose
Experimental
干预措施: Dabigatran low dose (Drug)
结局指标
主要结局
Occurrence of adverse events
时间窗: up to 10 days
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
时间窗: up to 7 days
Changes in QT(c) intervals
时间窗: up to 7 days
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
时间窗: up to 7 days
次要结局
- Cmax (maximum measured concentration)(day 1)
- tmax (time from dosing to maximum measured concentration)(day 1)
- AUCτ,1 (area under the concentration-time curve over a uniform dosing interval τ after administration of single dose on Day 1)(day 1)
- tmax,ss (time from last dosing to maximum concentration at steady state)(up to 7 days)
- Cmin,ss (minimum concentration at steady state over a uniform dosing interval τ)(up to 7 days)
- λz,ss (terminal rate constant at steady state)(up to 7 days)
- t1/2,ss (terminal half-life at steady state)(up to 7 days)
- MRTpo,ss (mean residence time in the body at steady state after oral administration)(up to 7 days)
- CL/F,ss (apparent clearance in the plasma at steady state after extravascular multiple dose administration)(up to 7 days)
- Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)(up to 7 days)
- RA,Cmax,13 (accumulation ratio calculated as Cmax,ss/Cmax)(up to 7 days)
- RA,AUC,13 (accumulation ratio calculated as AUCτ,ss/AUCτ,1)(up to 7 days)
- area under the curve for activated partial thromboplastin time (aPTT)(0 - 12 hours after adminstration on day 1 and day 7)
- area under the curve for ecarin clotting time (ECT)(0 - 12 hours after adminstration on day 1 and day 7)
- comparison of trough concentrations(after doses 3, 5, 7, 9, 11 and 13)
- comparison of trough concentrations morning versus evening(after doses 9, 10, 11, 12, 13)
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