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Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers

NCT04198948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-08-18

Study results available
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Summary

Proton pump inhibitors (PPIs) are treatment of choice for different gastrointestinal disorders common in type 2 diabetes. Sulfonylureas (SUs) are anti-diabetes agents particularly widely used in developing countries. Gliclazide, a recommended SU drug, is metabolised in part by CYP2C19, the main enzyme responsible for the PPI metabolism.

A randomised, placebo-controlled, two-sequence, two-period crossover study will be performed to explore whether gliclazide pharmacokinetics (PK) and pharmacodynamics (PD) are altered upon co-administration with omeprazole. Sixteen healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers (EM/UM), will receive placebo or omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. Plasma concentration of gliclazide will be measured for 24 hours, and plasma glucose and insulin levels up to 12 hours after gliclazide administration.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Omeprazole

Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.

DRUG

Placebo oral tablet

Placebo will be administered orally once daily for 5 days in one of the two treatment periods.

DRUG

Gliclazide

Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.

Sponsors & Collaborators

  • General Hospital Prim. Dr. Abdulah Nakas

    collaborator OTHER

  • University of Dundee

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • University of Sarajevo

    lead OTHER

Principal Investigators

  • Tanja Dujic, PhD · University of Sarajevo

  • Aida Kulo Cesic, PhD · University of Sarajevo

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2019-08-05
Completion
2019-08-05

Countries

  • Bosnia and Herzegovina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198948 on ClinicalTrials.gov