Adverse Drug Event, Drug-Induced Liver Injury, Tuberculosis
Conditions
Brief summary
A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects
Interventions
DRUGIsoniazid
One of the first line anti-tubercolosis drug
Sponsors
Ministry of Health & Welfare, Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Agreement with written informed consent * Adult healthy male or female subject age 20 to 45
Exclusion criteria
* Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver toxicity | up to 4 weeks | Number of participants with drug-induced liver injury as assessed by below criteria. * AST or ALT \> 5 ULN * AST or ALT \> 3 ULN and total bilirubin \> 2 ULN (Hy's law case) * ALT ratio/ALP ratio \> 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug exposure | Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose | Plasma isoniazid concentration |
Countries
South Korea
Outcome results
None listed