Tuberculosis Clinical Trial
Official title:
Clinical Trial to Investigate the Appropriate Dose of Isoniazid According to NAT2 Polymorphism Status in Korean Subjects
NCT number | NCT03665402 |
Other study ID # | INH NAT2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 13, 2018 |
Est. completion date | March 31, 2019 |
Verified date | December 2018 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects
Status | Completed |
Enrollment | 16 |
Est. completion date | March 31, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital Clinical Trials Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Ministry of Health & Welfare, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver toxicity | 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 |
up to 4 weeks | |
Secondary | Drug exposure | Plasma isoniazid concentration | Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose |
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