Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04198948
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2019-12-11
Brief Title:
Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal Ultrarapid Metabolisers
Sponsor:
University of Sarajevo
Organization:
University of Sarajevo
Study Overview
Official Title:
Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal Ultrarapid Metabolisers
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERGLIKOM
Brief 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 extensiveultrarapid metabolisers EMUM 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
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 extensiveultrarapid metabolisers EMUM 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 209943Z17Z | OTHER_GRANT | Wellcome Trust | None |