NCT01181505已完成1 期
STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Cmax, AUC, CL, Vd, T1/2
研究概览
简要总结
This study was to investigate the pharmacokinetics of tolterodine, substrate of CYP2D6 in healthy subject in relation to the presence of HNF-4A G60D variant.
详细描述
After a single oral administration of 2 mg tolterodine in 31 healthy subjects (6 with the heterozygous mutation of HNF-4A G60D vs 25 subjects with wild type of that whose CYP2D6 genotype and gender were matched with variant group), blood were collected for 24hrs. Assay of tolterodine and the metabolite, 5-hyroxymethyl tolterodine was conducted using LC/MS/MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject whose HNF4a and CYP2D6 genotype ware determined
排除标准
- •Subject whose HNF4a and CYP2D6 genotype ware not determined
研究组 & 干预措施
Tolterodine
Experimental
干预措施: Tolterodine (Drug)
结局指标
主要结局
Cmax, AUC, CL, Vd, T1/2
时间窗: 24hr
次要结局
未报告次要终点
研究者
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