TCTR20161227002Enrolling By Invitation未知
The relationship between genetic variations of CYP2A6 and pharmacokinetics of nicotine and hair nicotine metabolites in cigarette smokers visiting medical check-up clinic at King Chulalongkorn Memorial Hospital
the 90th Anniversary of Chulalongkorn University Fund (Ratchadaphiseksomphot Endowment Fund)0 个研究点目标入组 18 人开始时间: 2016年12月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Study I : Genotyping of CYP2A6
- •1. Thai smokers visiting medical check-up clinic at King Chulalongkorn Memorial Hospital
- •2. Age of smoker between 18-60 years
- •3. Current smoker and defined as smoking >100 cigarette at least 5 months determined by Fagerström Test for Nicotine Dependence (FTND) test
- •4. Written informed consent
- •Study II : Pharmacokinetics of nicotine
- •1. Thai smoker had normal metabolizers (CYP2A6*1A/*1A, CYP2A6*1A/*1B, and CYP2A6*1B/*1B) or slow metabolizers (CYP2A6*1A/*4, CYP2A6*1A/*9, CYP2A6*1B/*9, CYP2A6*9/*9, CYP2A6*4/*4, CYP2A6*4/*9 and CYP2A6*1B/*4)
- •2. Abstain from smoking (tobacco and nicotine replacement therapy) for 12 hours prior to the study
- •3. Agree to keep the hair root from the back of scalp length of 5 centimeters and 100 milligram of hairs
- •4. Written informed consent
排除标准
- •Study I : Genotyping of CYP2A6
- •1. Who had use medication within 14 days prior to the start of the study
- •2. Liver and kidney disease
- •3. During pregnancy or breast feeding
- •4. Participation in another clinical trial within 30 days
- •Study II : Pharmacokinetics of nicotine
- •1. Who had use medication within 14 days prior to the start of the study
- •2. Liver and kidney disease
- •3. During pregnancy or breast feeding
- •4. Who had a history of temporomandibular joint disease or pain
- •5. Participation in another clinical trial within 30 days
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