A Single Dose, Double-blind, Genotype-based Stratification Study to Explore the Pharmacokinetics and Pharmacodynamics of Amitriptyline According to CYP2D6 and CYP2C19 Polymorphisms in Healthy Korean Male Adult Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 主要终点
- Maximum concentration (Cmax) of Amitriptyline, 10-Hydroxy-amitriptyline, Nortriptyline, and 10-Hydroxy-nortriptyline
研究概览
简要总结
A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline, 25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and cytochrome P450 2C19 genotypes, and serial blood sampling will be done for plasma concentrations of amitriptyline, nortriptyline, and their metabolites. Various pharmacodynamic markers related to the adverse event of amitriptyline will be measured serially during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteer, age 19~45 years
- •The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
- •Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
- •Voluntarily signed the informed consent form
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
- •History of relevant drug allergies or clinically significant hypersensitivity reaction.
- •Smoked more than 10 cigarettes a day for past 3 months
- •Not eligible due to other reasons including laboratory results
研究组 & 干预措施
Amitriptyline
Single oral dose of amitriptyline, 25 mg
干预措施: Amitriptyline (Drug)
结局指标
主要结局
Maximum concentration (Cmax) of Amitriptyline, 10-Hydroxy-amitriptyline, Nortriptyline, and 10-Hydroxy-nortriptyline
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hour
Area under curve (AUC) of Amitriptyline, 10-Hydroxy-amitriptyline, Nortriptyline, and 10-Hydroxy-nortriptyline
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hour
次要结局
未报告次要终点
研究者
Hyeong-Seok Lim
Associate Professor
Asan Medical Center