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 sites18 target enrollmentStarted: December 27, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 60 Years (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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