An Open-label, Single-dose, Three-treatment, Three-period Study to Investigate the Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC of atenolol according to the SLCO2B1 genotypes
研究概览
简要总结
An open-label, single-dose, three-treatment, three-period study to investigate the effect of SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration in healthy male Korean.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 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 (atenolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
研究组 & 干预措施
1
SLCO2B1 wild type allele
干预措施: Atenolol (Drug)
1
SLCO2B1 wild type allele
干预措施: Atenolol with apple juice 1200 mL (Drug)
1
SLCO2B1 wild type allele
干预措施: Atenolol with apple juice 600 mL (Drug)
2
SLCO2B1 variant allele
干预措施: Atenolol (Drug)
2
SLCO2B1 variant allele
干预措施: Atenolol with apple juice 1200 mL (Drug)
2
SLCO2B1 variant allele
干预措施: Atenolol with apple juice 600 mL (Drug)
结局指标
主要结局
AUC of atenolol according to the SLCO2B1 genotypes
时间窗: 0-48 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 atenolol according to the SLCO2B1 genotypes(0-48 hr after drug admnistration)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(0-48 hr after drug admnistration)
研究者
In-Jin Jang, MD, PhD
Professor of Clinical Pharmacology and Therapeutics
Seoul National University Hospital