Pharmacokinetic, Pharmacodynamic Profiles and Safety After Oral Administration of Ivabradine in Male Healthy Korean Volunteers
2013年3月4日 更新者：Kyun-Seop Bae、Asan Medical Center
- To assess the pharmacokinetic profile of ivabradine (S 16257) and its main active metabolite S 18982 in Korean healthy volunteers after oral administration of ivabradine at the doses of 2.5, 5, 10mg and after repeated oral administrations of ivabradine for 4.5 days at the same doses twice daily versus placebo and to use the study results for bridging with Caucasian data.
- The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on heart rate after single and then after repeated administrations.
- Clinical safety of ivabradine versus placebo.
研究概览
研究类型
介入性
注册 (实际的)
48
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Seoul、大韩民国、138-736
- Asan Medical Center
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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
男性
描述
Inclusion Criteria:
- age between 18 and 40 years and Korean
- Nonsmoker or smoke less than 5 cigarettes per day
- normal dietary habits
- BMI ranging from 18 to 25 kg/m2
- good physical and mental status, determined by the investigator
- vital signs in resting condition within range: SBP 100-139 mmHg, DBP 50-89 mmHg
- Normal ECG
Exclusion Criteria:
- Participate any other trial in the last 3 months prior to the study
- History of major psychiatric, medical, surgical disorders
- Acute, or chronic disease
- History of hypersensitivity to at least one drug
- History of alcoholism or positive alcohol breath test
- Positive drug screening results
- known positive serology for HIV1, HIV2, hepatitis B or C
- blood donor within the last 3 month of the study
- regular use of sedatives, hypnotics, tranquillisers
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
安慰剂给药
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Single and repeated oral administrations of 3 doses of ivabradine (2.5, 5, and 10 mg).
Subjects were given a single administration of ivabradine during Period 1 (P1), following a 3-day washout, they were given repeated administrations twice daily for 4.5 days during Period 2 (P2).
其他名称：
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有源比较器：Ivabradine
Single and repeated oral administrations of 3 doses of ivabradine
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Single and repeated oral administrations of 3 doses of ivabradine (2.5, 5, and 10 mg).
Subjects were given a single administration of ivabradine during Period 1 (P1), following a 3-day washout, they were given repeated administrations twice daily for 4.5 days during Period 2 (P2).
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cmax,tmax, AUC(Area under the time-concentration curve) of ivabradine and metabolite
大体时间：within 60 days after blood sampling (blood sample analysis)
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For PK measurements, blood samplings were done: pre-dose then 20 min, 40 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h, 60 h, and 72 h following the D1 single administration (P1) and the Day 8 (D8) last repeated dose (P2), respectively.Ivabradine and its main metabolite were determined using LC-MS/MS, then pharmacokinetic parameters were calculated by noncompartmental approach.
Descriptive statistics were performed on the PK individual parameters calculated from the plasma concentration-time profiles.
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within 60 days after blood sampling (blood sample analysis)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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pharmacodynamics: The change of heart rate between baseline and over 24-hour, diurnal, nocturnal, awake, and asleep periods after administration of ivabradine
大体时间：within 10 days after administration
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For PD measurements, 24-hour Holter recordings were performed on Day0, Day1, Day8, and Day10. a resting 12-lead ECG were also performed. The changes of heart rate between day 1 and baseline values, between day 8 and baseline values were studied over 24-hour, diurnal, nocturnal, awake and asleep period for each ivabradine dose in comparison with placebo. Descriptive statistics by dose were performed and confidence intervals of the differences between each dose of ivabradine and placebo were constructed using a non-parametric method based on Hodges & Lehman estimate for independent samples. |
within 10 days after administration
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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。
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
2007年5月1日
初级完成 (实际的)
2007年9月1日
研究完成 (实际的)
2007年11月1日
研究注册日期
首次提交
2013年2月27日
首先提交符合 QC 标准的
2013年3月4日
首次发布 (估计)
2013年3月5日
研究记录更新
最后更新发布 (估计)
2013年3月5日
上次提交的符合 QC 标准的更新
2013年3月4日
最后验证
2013年3月1日
更多信息
与本研究相关的术语
其他研究编号
- 2007-0114
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.