At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
In Brief
A Phase 1 clinical trial evaluating Omeprazole, Placebo oral tablet, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.