Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Different Omeprazole Dosing on Gastric pH in Non-variceal Upper Gastrointestinal Bleeding

NCT03980496

Non-variceal Upper Gastrointestinal Bleeding

COMPLETED PHASE4

Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects

NCT01159145

Pharmacodynamics Study

COMPLETED PHASE1

Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers

NCT00519519

Bleeding Peptic Ulcers Disease

COMPLETED PHASE3

Prilosec Bioequivalence Study in Healthy Volunteers

NCT01921920

Bioequivalence, AUC, Cmax, Pharmacokinetics

COMPLETED PHASE1

Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot

NCT02536989

Peptic Ulcer Hemorrhage

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stomach Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CYP2C19 EM

Group Type EXPERIMENTAL

Omeprazole

Intervention Type DRUG

CYP2C19 IM

Group Type EXPERIMENTAL

Omeprazole

Intervention Type DRUG

CYP2C19 PM

Group Type EXPERIMENTAL

Omeprazole

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omeprazole

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes