A Clinical Trial to Investigate the Influence of Cytochrome P450 2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamics Characteristics of Carvedilol in Healthy Korean Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC (area under the plasma concentration-time curve) of carvedilol
研究概览
简要总结
A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol
详细描述
This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;
To evaluate the change of the result of Isoproterenol Sensitivity Test according to Cytochrome P450 2D6 genotype after the multiple administration of carvedilol
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects aged 20 - 45 years
- •A body mass index (BMI) in the range 18.0 kg/m2 (inclusive) - 27.0 kg/m2 (inclusive).
- •Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
排除标准
- •Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Carvedilol, Isoproterenol).
- •Subject judged not eligible for study participation by investigator.
研究组 & 干预措施
Carvedilol
- Day 1 to 3 : Carvedilol 12.5 mg qd
- Day 4 to 8 : Carvedilol 25 mg qd
- Day 9 to 11 : Carvedilol 12.5 mg qd
Isoproterenol Sensitivity Test
- Day 0, 1.5h post-dose Injection of isoproterenol 4 times (0.25, 0.5, 1, 2 ug/mL), time interval of 10 minutes.
- Day 1, 8, 1.5h post-dose Injection of isoproterenol 4 times (5, 10, 20, 40 ug/mL), time interval of 10 minutes.
Measure change of heart rates after 1, 2, 3 minutes post injection of isoproterenol.
干预措施: Carvedilol (Drug)
Carvedilol
- Day 1 to 3 : Carvedilol 12.5 mg qd
- Day 4 to 8 : Carvedilol 25 mg qd
- Day 9 to 11 : Carvedilol 12.5 mg qd
Isoproterenol Sensitivity Test
- Day 0, 1.5h post-dose Injection of isoproterenol 4 times (0.25, 0.5, 1, 2 ug/mL), time interval of 10 minutes.
- Day 1, 8, 1.5h post-dose Injection of isoproterenol 4 times (5, 10, 20, 40 ug/mL), time interval of 10 minutes.
Measure change of heart rates after 1, 2, 3 minutes post injection of isoproterenol.
干预措施: Isoproterenol Sensitivity Test (Other)
结局指标
主要结局
AUC (area under the plasma concentration-time curve) of carvedilol
时间窗: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose
Cmax (Maximum plasma concentration) of carvedilol
时间窗: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose
次要结局
未报告次要终点
研究者
Jae Yong Chung
Associate Professor
Seoul National University Hospital