Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

Phase 1

Completed

• Conditions: Stomach Ulcer
• Interventions: Drug: Omeprazole

• Registration Number: NCT02299687
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-21
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Last Update Submitted: 2014-12-31
• Last Update Posted: 2015-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Are able to provide written informed consent.
2. The subject is a healthy Korean aged 20 to 45 years, inclusive.
3. 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

1. Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
2. Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
3. Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
4. 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.)
5. 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
6. Subject who have history of allergy on omeprazole
7. Subject who can not continue proper contraception method during study period.
8. Subject with a positive urine HCG test result on screening. (in case of woman subject)
9. 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
10. Subjects who consume more than 10 cigarette per day or who are unable to abstain from smoking during the PK/PD testing period
11. Subjects who are unable to abstain from grapefruit or caffeine containing food 3 day prior the first administration of the investigational product
12. Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYP2C19 EM	Omeprazole	CYP2C19 EM
CYP2C19 IM	Omeprazole	CYP2C19 IM
CYP2C19 PM	Omeprazole	CYP2C19 PM

Primary Outcome Measures

Name	Time	Method
mean and median Intragastric PH	24 hour

Secondary Outcome Measures

Name	Time	Method
AUC	12 hour
Cmax	12 hour

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of