Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

AstraZeneca1 site in 1 country11 target enrollmentMay 2008

ConditionsDiabetes Mellitus, Type 2

InterventionsDapagliflozin Glimepiride Dapagliflozin + Glimepiride

DrugsDapagliflozin Glimepiride Dapagliflozin + Glimepiride

Overview

Phase: Phase 1
Intervention: Dapagliflozin
Conditions: Diabetes Mellitus, Type 2
Sponsor: AstraZeneca
Enrollment: 11
Locations: 1
Primary Endpoint: Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

August 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects with BMI of 18-32 kg/m2

Exclusion Criteria

•Abnormal physical or lab findings
•Allergies to any sulfonylurea or related compounds

Arms & Interventions

Arm 1

Intervention: Dapagliflozin

Arm 2

Intervention: Glimepiride

Arm 3

Intervention: Dapagliflozin + Glimepiride

Outcomes

Primary Outcomes

Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together

Time Frame: plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose

Secondary Outcomes

Recorded adverse events(for 72 hours after each administered dose)
Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride(for 72 hours after each administered dose)