An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- AUC of acebutolol according to the SLCO2B1 genotypes
研究概览
简要总结
An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures
排除标准
- •A subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
研究组 & 干预措施
Acebutolol
Acebutolol 200 mg capsule (Acetanol®)
干预措施: Acebutolol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
AUC of acebutolol according to the SLCO2B1 genotypes
时间窗: 0-24 hr after drug administration
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear/log trapezoidal method will be summarized by treatment and genotype group using descriptive statistics.
次要结局
- Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes(0-24 hr after drug admnistration)
研究者
In-Jin Jang, MD, PhD
Professor of Clinical Pharmacology and Therapeutics
Seoul National University Hospital