NCT04198948

Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Sarajevo · Academic / Other
• Sex: Male
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-03-04
• Primary completion: 2019-08-05
• Completion: 2019-08-05
• First posted: 2019-12-13
• Last updated: 2021-08-18
• Results posted: 2021-07-15

Locations

1 site across 1 country: Bosnia and Herzegovina