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Relative Bioavailability of Telmisartan and Dipyridamole After Co-administration Compared to the Bioavailability of Telmisartan or Dipyridamole Alone in Healthy Female and Male Subjects

2014年10月10日 更新者:Boehringer Ingelheim

Relative Bioavailability of Telmisartan in Micardis® and of Dipyridamole in Aggrenox® After Co-administration Compared to the Bioavailability of Telmisartan Respectively of Dipyridamole After Oral Administration of 80 mg Telmisartan Respectively of 25 mg ASA/200 mg Extended-release Dipyridamole Alone. An Open-label, Randomised, Single-dose, Four-way Crossover Study in 24 Healthy Female and Male Subjects

To investigate the relative bioavailability of telmisartan respectively of dipyridamole after concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).

To investigate the relative bioavailability of dipyridamole respectively of telmisartan administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2) relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

24

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

21年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Healthy females and 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

    • No finding deviating from normal and of clinical relevance
    • No evidence of a clinically relevant concomitant disease
  2. Age ≥21 and Age ≤65 years
  3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  2. Surgery of gastrointestinal tract (except appendectomy)
  3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  4. History of relevant orthostatic hypotension, fainting spells or blackouts.
  5. Chronic or relevant acute infections
  6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  7. 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
  8. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  9. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  10. Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)
  11. Inability to refrain from smoking on trial days
  12. Alcohol abuse (more than 60 g/day)
  13. Drug abuse
  14. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  15. Excessive physical activities (within one week prior to administration or during the trial)
  16. Any laboratory value outside the reference range that is of clinical relevance
  17. Inability to comply with dietary regimen of study centre
  18. History of hereditary fructose intolerance
  19. History of any familial bleeding disorder
  20. Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)
  21. Inability to comply with the investigators instructions

    For female subjects:

  22. Pregnancy
  23. Positive pregnancy test
  24. No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
  25. Inability to maintain this adequate contraception during the whole study period
  26. Lactation period

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:telmisartan and ASA/ER-DP (concomitant)
有源比较器:ASA/ER-DP alone
实验性的:telmisartan and ASA/ER-DP (consecutively)
有源比较器:telmisartan

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 in plasma from 0 extrapolated to infinity)
大体时间:up to 72 hours following drug administration
up to 72 hours following drug administration
Cmax (maximum concentration in plasma)
大体时间:up to 72 hours following drug administration
up to 72 hours following drug administration

次要结果测量

结果测量
措施说明
大体时间
发生不良事件的受试者数量
大体时间:最后一次给药后最多 8 天
最后一次给药后最多 8 天
在实验室测试中具有临床重要发现的受试者人数
大体时间:最后一次给药后最多 8 天
最后一次给药后最多 8 天
AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)
大体时间:up to 72 hours following drug administration
up to 72 hours following drug administration
AUCt1-t2 (Area under the concentration time curve in plasma over the time interval t1 to t2)
大体时间:up to 72 hours following drug administration
up to 72 hours following drug administration
tmax (time from dosing to the maximum concentration of the analytes in plasma)
大体时间:up to 72 hours following drug administration
up to 72 hours following drug administration
λz (terminal rate constant in plasma)
大体时间:up to 72 hours following drug administration
up to 72 hours following drug administration
t1/2 (terminal half-life of the analytes in plasma)
大体时间:up to 72 hours following drug administration
up to 72 hours following drug administration
MRTpo (mean residence time of the analyte in the body after p.o. administration)
大体时间:up to 72 hours following drug administration
up to 72 hours following drug administration
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
大体时间:up to 72 hours following drug administration
up to 72 hours following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
大体时间:up to 72 hours following drug administration
up to 72 hours following drug administration
Number of subjects with clinically significant findings in vital signs
大体时间:up to 8 days after last drug administration
blood pressure, heart rate
up to 8 days after last drug administration
Number of subjects with clinically significant findings in 12 lead ECG
大体时间:up to 8 days after last drug administration
up to 8 days after last drug administration
Assessment of tolerability by the investigator on a 4-point scale
大体时间:up to 8 days after last drug administration
up to 8 days after last drug administration

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

2004年5月1日

初级完成 (实际的)

2004年7月1日

研究注册日期

首次提交

2014年10月10日

首先提交符合 QC 标准的

2014年10月10日

首次发布 (估计)

2014年10月13日

研究记录更新

最后更新发布 (估计)

2014年10月13日

上次提交的符合 QC 标准的更新

2014年10月10日

最后验证

2014年10月1日

更多信息

与本研究相关的术语

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.

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