A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status
NCT ID: NCT03665402
Last Updated: 2020-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2018-05-13
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Rapid metabolizer (Standard treatment)
Standard isoniazid dose regimen (300 mg qd)
Isoniazid
One of the first line anti-tubercolosis drug
Slow metabolizer (Standard treatment)
Standard isoniazid dose regimen (300 mg qd)
Isoniazid
One of the first line anti-tubercolosis drug
Slow metabolizer (PGx treatment)
Decreased isoniazid dose regimen (200 mg qd)
Isoniazid
One of the first line anti-tubercolosis drug
Interventions
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Isoniazid
One of the first line anti-tubercolosis drug
Eligibility Criteria
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Inclusion Criteria
* Adult healthy male or female subject age 20 to 45
Exclusion Criteria
* Medication with any drug which may affect the pharmacokinetics of isoniazid within 14 days
* Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
* Subject with known for hypersensitivity reactions to isoniazid
* Subject who can not perform contraception during study periods
* Female woman who are pregnant or are breast feeding
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
20 Years
45 Years
ALL
Yes
Sponsors
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Ministry of Health & Welfare, Korea
OTHER_GOV
Seoul National University Hospital
OTHER
Responsible Party
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Locations
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Seoul National University Hospital Clinical Trials Center
Seoul, , South Korea
Countries
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Other Identifiers
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INH NAT2
Identifier Type: -
Identifier Source: org_study_id
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