Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
2014年10月23日 更新者:Boehringer Ingelheim
A Double-blind, Randomised, 3-way Cross-over Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin ER Extended Release (ER) 200 mg Dipyridamole/25 mg ASA Formulations in Healthy Male and Female Volunteers
Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
18
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 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)
- Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent
- Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG
- Hematopoietic, hepatic and renal function tests will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
- The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Exclusion Criteria:
- Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Subjects with chronic or relevant acute infections
- Subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study
- Volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study
- Volunteers who participate in another study with an investigational drug within the last two months preceding the study
- Volunteers who are unable to refrain from smoking on study days
- Volunteers who smoke more than10 cigarettes (or equivalent) per day
- Volunteers who drink more than 60 g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who donate blood (≥ 100 mL) within the last four weeks
- Volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports)
- Volunteers who suffer from any other disease or abnormality of clinical relevance
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- History of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
Female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (IUD), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- 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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Asasantin ER,目前的商业配方
|
|
实验性的:Asasantin ER, new formulation I
|
|
实验性的:Asasantin ER, new formulation II
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)
大体时间:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Percent peak trough fluctuation of dipyridamole in plasma (%PTF)
大体时间:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)
大体时间:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
大体时间:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)
大体时间:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)
大体时间:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Terminal half-life of the analytes in plasma (t1/2)
大体时间:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Percent of dose of the analytes recovered unchanged in urine (Ae%)
大体时间:Up to 24 hours after start of drug administration
|
Up to 24 hours after start of drug administration
|
Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)
大体时间:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)
大体时间:up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Number of subjects with clinically relevant changes in 12-lead ECG
大体时间:up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Number of subjects with clinically relevant changes in laboratory values
大体时间:up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Number of subjects with adverse events
大体时间:up to 8 days after last study drug administration
|
up to 8 days after last study 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
2001年4月1日
初级完成 (实际的)
2001年5月1日
研究注册日期
首次提交
2014年10月23日
首先提交符合 QC 标准的
2014年10月23日
首次发布 (估计)
2014年10月24日
研究记录更新
最后更新发布 (估计)
2014年10月24日
上次提交的符合 QC 标准的更新
2014年10月23日
最后验证
2014年10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
- 9.144
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Asasantin ER,目前的商业配方的临床试验
-
Boehringer Ingelheim完全的