Status:
COMPLETED
Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole
Lead Sponsor:
Seoul National University Hospital
Conditions:
Stomach Ulcer
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
A clinical trial to investigate the influence of CYP2C19 polymorphism on pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02299687
Start Date
September 1 2014
Last Update
January 1 2015
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea