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Correlation of CYP2D6 polymorphisms and pharmacokinetics of primaquine in Thai army Population on the Thailand-Cambodia border area

Correlation of CYP2D6 polymorphisms and pharmacokinetics of primaquine in Thai army Population on the Thailand-Cambodia border area

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190211002
Enrollment
345
Registered
2019-02-11
Start date
2018-09-04
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thai armies who are at risk of malaria Plasmodium vivax malaria&#44

Interventions

&#45
Experimental Drug,Experimental Drug,Experimental Drug
CYP2D6 Normal metabolizer,CYP2D6 intermediate metabolizer,CYP2D6 poor metabolizer

Sponsors

Chulalongkorn university
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
PK parameters of primaqine (PQ) and 5,6-o-PQ in CYP2D6 genetic different Thai army population after drug administration LC-MS/MS

Secondary

MeasureTime frame
Frequency of CYP2D6 genetic polymorphisms in Thai army population after participants signed informed consent Real-time PCR and Extra-long PCR

Countries

Thailand

Contacts

Public ContactWaritda Pookmanee

Royal Thai Army, Medical Depot Division.

waritda@hotmail.com0850329987

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026