NCT03665402已完成不适用
Clinical Trial to Investigate the Appropriate Dose of Isoniazid According to NAT2 Polymorphism Status in Korean Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Liver toxicity
研究概览
简要总结
A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agreement with written informed consent
- •Adult healthy male or female subject age 20 to 45
排除标准
- •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
研究组 & 干预措施
Rapid metabolizer (Standard treatment)
Active Comparator
Standard isoniazid dose regimen (300 mg qd)
干预措施: Isoniazid (Drug)
Slow metabolizer (Standard treatment)
Active Comparator
Standard isoniazid dose regimen (300 mg qd)
干预措施: Isoniazid (Drug)
Slow metabolizer (PGx treatment)
Experimental
Decreased isoniazid dose regimen (200 mg qd)
干预措施: Isoniazid (Drug)
结局指标
主要结局
Liver toxicity
时间窗: 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
次要结局
- Drug exposure(Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis PreventionTuberculosis InfectionIsoniazid Adverse ReactionNCT05413551Stanford University73
已完成
2 期
A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal TherapyProstate CancerNCT00887458Johns Hopkins University46
招募中
2 期
A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.Carcinoma, HepatocellularNCT06349980Shanghai Henlius Biotech117
已完成
2 期
Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.Trypanosoma Cruzi InfectionChagas DiseaseNCT03191162Hospital Universitari Vall d'Hebron Research Institute238
进行中（未招募）
1 期
Ensayo clínico de fase II, de optimización de dosis, abierto, de Zalypsis® (PM00104) en pacientes con mieloma múltiple recaído/refractarioMieloma Múltiple recaído / refractarioEUCTR2009-016054-40-ESPharmaMar S.A.36