NCT02299687已完成1 期
A Clinical Trial to Investigate the Influence of CYP2C19 Polymorphism on Pharmacokinetic/Pharmacodynamic Characteristics of Omeprazole in Healthy Korean Volunteers
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
- 24
- 试验地点
- 1
- 主要终点
- mean and median Intragastric PH
研究概览
简要总结
A clinical trial to investigate the influence of CYP2C19 polymorphism on pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Are able to provide written informed consent.
- •The subject is a healthy Korean aged 20 to 45 years, inclusive.
- •The subject weighs at least 55 (for female, 55) to 90 kg and has a body mass index (BMI) range of 18 to 25 kg/m2
排除标准
- •Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
- •Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
- •Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
- •Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.)
- •Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product
- •Subject who have history of allergy on omeprazole
- •Subject who can not continue proper contraception method during study period.
- •Subject with a positive urine HCG test result on screening. (in case of woman subject)
- •Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period
- •Subjects who consume more than 10 cigarette per day or who are unable to abstain from smoking during the PK/PD testing period
- •Subjects who are unable to abstain from grapefruit or caffeine containing food 3 day prior the first administration of the investigational product
- •Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.
研究组 & 干预措施
CYP2C19 EM
Experimental
CYP2C19 EM
干预措施: Omeprazole (Drug)
CYP2C19 IM
Experimental
CYP2C19 IM
干预措施: Omeprazole (Drug)
CYP2C19 PM
Experimental
CYP2C19 PM
干预措施: Omeprazole (Drug)
结局指标
主要结局
mean and median Intragastric PH
时间窗: 24 hour
次要结局
- AUC(12 hour)
- Cmax(12 hour)
研究者
In-Jin Jang, MD, PhD
Professor of clinical pharmacology
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of VoriconazoleHealthyNCT00942773Seoul National University Hospital18
已完成
不适用
Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.Neonatal SeizureNCT01224457Yonsei University52
已完成
1 期
Cytochrome P450 2D6 Genotype on the Clinical Effect of CarvedilolHealthyNCT02286934Seoul National University Hospital24
已完成
4 期
Impact of CYP2C19 Genotype-guided Clopidogrel and Ticagrelor Treatment on Platelet Function Test and Metabolomics ProfileCoronary Artery Disease (CAD)NCT05516784Universiti Sains Malaysia80
Unknown
不适用
The Role of CYP2C19 on the Eradication of H. Pylori Infection:Implication of PK/PD RelationshipsPeptic Ulcer With H. Pylori InfectionGastritis With H. Pylori InfectionNCT00162877National Taiwan University Hospital80