Bioavailability and Pharmacokinetics of BI 10773 Tablet in Healthy Male Volunteers
2014年6月20日 更新者:Boehringer Ingelheim
The Effect of Food on the Bioavailability and Pharmacokinetics of BI 10773 Tablet, Administered as a Single Dose of 50 mg With and Without Food to Healthy Male Volunteers in an Open-label, Randomised Intraindividual Crossover Comparison Design
Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a single dose BI 10773 tablet in healthy subjects
研究概览
研究类型
介入性
注册 (实际的)
14
阶段
- 阶段1
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
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- Age ≥ 18 and Age ≤ 55 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Exclusion Criteria:
- Any finding in the medical examination (including BP (blood pressure), PR (pulse rate) and ECG (electrocardiogram)) 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 or 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 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 on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- 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 the 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 de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
- Elevated urinary glucose levels at screening (> 15 mg/dl; > 0.83 mmol/L)
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 |
---|---|
实验性的:BI 10773 tablet administered with food
50 mg BI 10773 after a standardised high fat breakfast
|
|
有源比较器:BI 10773 tablet administered to fasted subjects
50 mg BI 10773 p.o. after an overnight fast of at least 10 hours
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
大体时间:Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Cmax (maximum measured concentration of the analyte in plasma)
大体时间:Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
次要结果测量
结果测量 |
大体时间 |
---|---|
tmax (time from dosing to the maximum concentration of the analyte in plasma)
大体时间:Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
t1/2 (terminal half-life of the analyte in plasma)
大体时间:Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours after last dose
|
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours after last dose
|
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
大体时间:Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
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)
大体时间:Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
λz (terminal rate constant in plasma)
大体时间:Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
MRTpo (mean residence time of the analyte in the body after p.o. administration)
大体时间:Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
大体时间:Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
大体时间:Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
|
Glucose excretion in urine
大体时间:pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose
|
pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose
|
Creatinine excretion in urine
大体时间:pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose
|
pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose
|
Abnormal findings in physical examination
大体时间:Baseline and within 14 days after last trial procedure
|
Baseline and within 14 days after last trial procedure
|
Changes from baseline in vital signs (blood pressure, pulse rate)
大体时间:Baseline and within 14 days after last trial procedure
|
Baseline and within 14 days after last trial procedure
|
Changes from baseline in 12-lead ECG (electrocardiogram)
大体时间:Baseline and within 14 days after last trial procedure
|
Baseline and within 14 days after last trial procedure
|
Changes from baseline in routine laboratory tests
大体时间:Baseline and within 14 days after last trial procedure
|
Baseline and within 14 days after last trial procedure
|
不良事件发生率
大体时间:最多 15 天
|
最多 15 天
|
Assessment of tolerability by investigator on a 4-point scale
大体时间:Within 14 days after last trial procedure
|
Within 14 days after last trial procedure
|
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
2008年1月1日
初级完成 (实际的)
2008年2月1日
研究注册日期
首次提交
2014年6月20日
首先提交符合 QC 标准的
2014年6月20日
首次发布 (估计)
2014年6月24日
研究记录更新
最后更新发布 (估计)
2014年6月24日
上次提交的符合 QC 标准的更新
2014年6月20日
最后验证
2014年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 1245.3
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.
BI 10773的临床试验
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