A Phase 3 interventional study of Empagliflozin 10 milligram in Pharmacogenomic and Pharmacokinetics, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Ain Shams University · Phase 3, Interventional, and Other
The aim of this works is to investigate the effect of genetic polymorphism of snps on human response to treatment with empagliflozin and its correlation with with pharmacokinetic parameters in Egyptian subjects
Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, therefore resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia and also assists weight loss and blood pressure reduction.
ABSORPTION Following oral administration, peak plasma concentrations were reached at 1.5 hours post-dose and then declined in a biphasic manner with a rapid distribution phase and a relatively slow terminal phase. Administration following a high-fat and high-calorie meal results in a slightly lower exposure with area under the curve (AUC) decreasing by approximately 16% and Cmax decreasing by approximately 37% compared to fasted condition.
METABOLISM In vitro studies suggest that empagliflozin is primarily metabolized by glucuronidation by 5'-diphospho-glucuronosyltransferases UG2B7, UGT1A3, UGT1A8, and UGT1A9. The most abundant metabolites are three glucuronide metabolites: 2-O-, 3-O-, and 6-O-glucuronide. Empagliflozin does not inhibit, inactivate, or induce CYP450 isoforms. It is a substrate for p-glycoprotein (p-gp), however in vitro studies suggest that it is unlikely to cause interactions with drugs that are p-gp substrates.
After oral administration, empagliflozin was 41.2% eliminated in feces and 54.4% eliminated in urine.
Terminal elimination half life was found to be 12.4 h based on population pharmacokinetic analysis.
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
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Exclusion Criteria:
Empagliflozin
Drug: Empagliflozin 10 milligram
antihyperglycemic medication
Also known as: Jardiance
Pharmacokinetic parameters
AUC0→∞
Time frame: 48 hours
Bioavailability parameters
Cmax
Time frame: 24 hours
Secondary outcome
Tmax
Time frame: 48 hours
Plan to share: No
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Ain Shams University