NCT02143323已完成1 期
A Clinical Study to Evaluate the Effect of Glutathion S-transferase Polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Amoxicillin/Clavulanate and Explore Biomarkers for Drug-induced Liver Injury (DILI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Alanine Aminotransferase (ALT)
研究概览
简要总结
This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;
- To evaluate the change of liver function according to glutathione s-transferase (GST) genotype after the multiple administration of amoxicillin/clavulanate.
- To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Subject with sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures
- •Healthy male of female subjects aged 20 - 45 years
- •Subjects whose body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (exclusive)
排除标准
- •Subject with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
- •Subject who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration
- •Subject who did blood donation during 1 months before the study or Blood donation during 2 months before the study
- •Subject with presence or history of severe adverse reaction to study drug
- •Subject who cannot prevent pregnancy during the study period.
- •Female subject who are pregnant.
- •Subject who drank over 21 units/week of alcohol or subjects who would not be able to stop drinking alcohol during the hospitalization
- •Subject who are Heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization.
- •Subject judged not eligible for study participation by investigator.
研究组 & 干预措施
Glutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild
Active Comparator
Augmentin tablet
干预措施: Augmentin tablet (Drug)
GSTT1/GSTM1 wild/null type
Active Comparator
Augmentin tablet
干预措施: Augmentin tablet (Drug)
GSTT1/GSTM1 null/wild type
Active Comparator
Augmentin tablet
干预措施: Augmentin tablet (Drug)
GSTT1/GSTM1 null/null type
Active Comparator
Augmentin tablet
干预措施: Augmentin tablet (Drug)
结局指标
主要结局
Alanine Aminotransferase (ALT)
时间窗: 22 days
Alkaline phosphatase (ALP)
时间窗: 22 days
Aspartate Aminotransferase (AST)
时间窗: 22 days
次要结局
未报告次要终点
研究者
In-Jin Jang, MD, PhD
Professor
Seoul National University Hospital
研究点 (2)
Loading locations...
相似试验
招募中
3 期
PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia GravisGeneralized Myasthenia GravisgMGNCT06607627Alexion Pharmaceuticals, Inc.12
已完成
1 期
Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074Drug InteractionNCT03385525Biogen30
已完成
1 期
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy SubjectsHealthyNCT05030857Galapagos NV19
已完成
1 期
PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy VolunteersChronic Obstructive Pulmonary DiseaseNCT05431426Chiesi Farmaceutici S.p.A.44
已完成
3 期
A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)Type 2 DiabetesChronic Kidney DiseaseNCT01621178Eli Lilly and Company577