TCTR20190211002Enrolling By InvitationPhase 4
Correlation of CYP2D6 polymorphisms and pharmacokinetics of primaquine in Thai army Population on the Thailand-Cambodia border area
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Enrolling By Invitation
- Sponsor
- Chulalongkorn university
- Enrollment
- 345
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 60 Years (—)
- Sex
- Male
Inclusion Criteria
- •For CYP2D6 gene analysis
- •1. Thai army male who has been performed in Thai-Cambodia border areas
- •2. Aged 18 to 60 years
- •3. Who had a history with malaria infection from the Thai-Cambodia border area (between January 1, 2012 and December 31, 2017)
- •For primaquine pharmacokinetics analysis
- •1. Participants in CYP2D6 gene analysis and known CYP2D6 status as PM, IM, NM
- •2. Aged 18 to 60 years
- •3. Who has a normal BMI (18 to 25 kg/m2)
- •4. Who has a normal physical examination
Exclusion Criteria
- •For primaquine pharmacokinetics analysis
- •1. Who continue receiving food supplement, herb, and medication regularly esp. CYP2D6 inhibitor(s), ABC transporter inhibitor esp. P-gp inhibitor(s)
- •2. Who received antimalarial treatment during the preceding 4 weeks
- •3. Who currently has malaria infection and signs of severe malaria
- •4. Who had an underlying disease that contraindication and/or precaution in primaquine using
- •5. Who had a history of gastrointestinal diseases, hepatic disease, kidney disease
- •6. Who knew a history of G6PD deficiency
- •7. Who is smoking
- •8. Who is drinking alcohol regularly; hazardous (8-15 scores), harmful (16 to 19 scores) and alcohol dependence (more than 20 scores) according to AUDIT
- •9. Who had a history of substance or drug addiction
Investigators
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