Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers
2015年5月1日 更新者：Boehringer Ingelheim
Relative Bioavailability of Dabigatran After Administration of Different Dosage Forms of Multiple Doses of 150 mg Dabigatran Etexilate (Hard Capsule, Granules Resolved in Reconstitution Solution, Pellets on Food) in Healthy Male Volunteers (an Open-label, Randomised, Multiple-dose, Three Way Crossover Study)
To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration.
To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation
研究概览
研究类型
介入性
注册 (实际的)
54
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Biberach、德国
- 1160.194.1 Boehringer Ingelheim Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion criteria:
- Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests
- Age 18 to 55 years (incl.)
- Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria:
- Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator.
- Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:
- Hemorrhagic disorders or bleeding diathesis
- Occult blood in faeces or haematuria
- Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation
- History of arteriovenous malformation or aneurysm
- History of gastroduodenal ulcer disease or gastrointestinal haemorrhage
- History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
- Anemia at screening
- Thrombocytopenia (platelet count less than 100/nL)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Test 1 (Treatment A)
multiple dose of dabigatran
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Pellets (multiple dose of dabigatran)
Granules resolved in reconstitution solution (multiple dose of dabigatran)
Hard capsule (multiple dose of dabigatran)
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实验性的：Test 2 (Treatment B)
multiple dose of dabigatran
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Pellets (multiple dose of dabigatran)
Granules resolved in reconstitution solution (multiple dose of dabigatran)
Hard capsule (multiple dose of dabigatran)
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实验性的：Reference
multiple dose of dabigatran
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Pellets (multiple dose of dabigatran)
Granules resolved in reconstitution solution (multiple dose of dabigatran)
Hard capsule (multiple dose of dabigatran)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.
大体时间：47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
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Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.
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47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
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Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.
大体时间：47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
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Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.
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47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.
大体时间：47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
|
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.
|
47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
|
|
Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.
大体时间：47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
|
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.
|
47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
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Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.
大体时间：once on day 3 (48 hours after first dose)
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Acceptability question: "Would you accept to take this medication for chronic use?" with 3 possible answers: Yes - No - I am not sure.
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once on day 3 (48 hours after first dose)
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Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.
大体时间：once on day 3 (48 hours after first dose)
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Palatability question: "How do you rank the taste?" with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable.
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once on day 3 (48 hours after first dose)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年1月1日
初级完成 (实际的)
2014年4月1日
研究完成 (实际的)
2014年4月1日
研究注册日期
首次提交
2014年1月22日
首先提交符合 QC 标准的
2014年1月22日
首次发布 (估计)
2014年1月24日
研究记录更新
最后更新发布 (估计)
2015年5月20日
上次提交的符合 QC 标准的更新
2015年5月1日
最后验证
2015年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.