Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

December 31, 2014 updated by: In-Jin Jang, MD, PhD, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CYP2C19 EM
Drug: Omeprazole
Experimental: CYP2C19 IM
Drug: Omeprazole
Experimental: CYP2C19 PM
Drug: Omeprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean and median Intragastric PH
Time Frame: 24 hour
24 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC
Time Frame: 12 hour
12 hour
Cmax
Time Frame: 12 hour
12 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 21, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

January 1, 2015

Last Update Submitted That Met QC Criteria

December 31, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMP_CYP2C19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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