Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)
2018年8月29日 更新者:Boehringer Ingelheim
An Open, Uncontrolled Trial in Healthy Volunteers to Explore the Plasma and Urinary Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)
To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf Extract (Antistax®).
Additionally, the trial evaluated the safety and tolerability of this dose in healthy subjects.
研究概览
研究类型
介入性
注册 (实际的)
12
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 40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:
- male or female (if female: either of non-childbearing potential or taking adequate contraceptive measures)
- caucasian
- age: 18 to 40 years old
- body mass index (BMI): 18-28 kg x m-2
- subjects who - on the basis of extensive pre-trial investigation - could be considered to be healthy
- subjects who were willing and capable to confirm written consent to enrolment after ample information has been provided
Exclusion Criteria:
- if female: positive pregnancy test upon recruitment
- subjects with any relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs)
- subjects with chronic or relevant acute infections
- subjects with therapy-requiring allergies (including drug allergies)
- subjects with suspicion of hypersensitivity to the investigational medication
- subjects with any clinically relevant laboratory abnormality (including positive results for hepatitis and HIV serology)
- subjects who had received any medication within 1 week prior to trial start or during the trial, except for hormonal contraceptives (females) or thyroid hormone replacement after thyroidectomy
- subjects who had taken a drug with a long half-life (≥ 24 hours) within one month before enrolment in the trial
- subjects who participated in a trial with a novel investigational medication within the last 8 weeks before the start of the present trial
- subjects who participated in a trial with a registered compound within the last 4 weeks before the start of the present trial
- subjects who donated blood or plasma within the last 4 weeks before the start of the present trial
- subjects who smoked more than 15 cigarettes per day and subjects who were not willing or able to abstain from smoking from 12:00 hours before and during the profiling days
- subjects known or suspected to be (social) drug dependent, incl. those drinking more than 60 g alcohol per day and who were not willing to abstain from alcohol during the active trial phase
- subjects adhering to a diet (i.e. vegetarian) or lifestyle (including extreme physical activities such as competitive sports and weight lifting) that might interfere with the investigation
- subjects known or suspected not to comply with the trial directives and/or known or suspected not to be reliable or trustworthy
- subjects known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
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
- 分配:不适用
- 介入模型:单组作业
- 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:Red Vine Leaf Extract
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
maximum concentration of the analyte (Cmax)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
area under the curve (AUC) extrapolated to infinity (AUC0-inf)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
次要结果测量
结果测量 |
大体时间 |
---|---|
平均停留时间 (MRT)
大体时间:给药后最多 24 小时
|
给药后最多 24 小时
|
time to Cmax (Tmax)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
AUC under the time course of the quantifiable concentrations (AUC0-tz)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
apparent terminal disposition rate constant (λz)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
apparent terminal half-life (t1/2)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after 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8月1日
初级完成 (实际的)
2004年9月1日
研究注册日期
首次提交
2014年7月15日
首先提交符合 QC 标准的
2014年7月15日
首次发布 (估计)
2014年7月16日
研究记录更新
最后更新发布 (实际的)
2018年8月31日
上次提交的符合 QC 标准的更新
2018年8月29日
最后验证
2018年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 1138.9
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