Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
Status:
Completed
Trial end date:
2019-08-05
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
University of Sarajevo
Collaborators:
General Hospital Prim. Dr. Abdulah Nakas University of Dundee Wellcome Trust