Relative Bioavailability of Telmisartan and Dipyridamole After Co-administration Compared to the Bioavailability of Telmisartan or Dipyridamole Alone in Healthy Female and Male Subjects
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
研究类型
注册 (实际的)
阶段
- 阶段1
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
- Age ≥21 and Age ≤65 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 (GCP) and the local legislation
Exclusion Criteria:
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of 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 allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- 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 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 (more than 10 cigarettes/day or 3 cigars/day 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 dietary regimen of study centre
- History of hereditary fructose intolerance
- History of any familial bleeding disorder
- 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.)
Inability to comply with the investigators instructions
For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
学习计划
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
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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
- 502.458
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