Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

Study Overview
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Brief Summary
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A clinical trial to investigate the influence of CYP2C19 polymorphism on pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers

Official Title
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A Clinical Trial to Investigate the Influence of CYP2C19 Polymorphism on Pharmacokinetic/Pharmacodynamic Characteristics of Omeprazole in Healthy Korean Volunteers

Conditions
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Stomach Ulcer

Intervention / Treatment
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* Drug: Omeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CYP2C19 EM<br>CYP2C19 EM | Drug: Omeprazole<br> <br> |
| Experimental: CYP2C19 IM<br>CYP2C19 IM | Drug: Omeprazole<br> <br> |
| Experimental: CYP2C19 PM<br>CYP2C19 PM | Drug: Omeprazole<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean and median Intragastric PH |  | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | 12 hour | 
| Cmax |  | 12 hour |