Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects

AstraZeneca1 site in 1 country18 target enrollmentNovember 2007

ConditionsHealthy Male and Female Subjects

InterventionsDapagliflozin Metformin Dapagliflozin + Metformin

DrugsDapagliflozin Metformin Dapagliflozin + Metformin

Overview

Phase: Phase 1
Intervention: Dapagliflozin
Conditions: Healthy Male and Female Subjects
Sponsor: AstraZeneca
Enrollment: 18
Locations: 1
Primary Endpoint: To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment
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 metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

February 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 men and women, ages 18-45 with a body mass index of 18-32 kg/m2

Exclusion Criteria

•Unwilling to use acceptable method of birth control
•current or recent (within 1 month) smoker
•abnormal liver function tests
•presence of edema
•history of diabetes mellitus
•history of heart failure or renal insufficiency
•history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
•history of Hepatitis C

Arms & Interventions

1

Intervention: Dapagliflozin

2

Intervention: Metformin

3

Intervention: Dapagliflozin + Metformin

Outcomes

Primary Outcomes

To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment

Time Frame: measures taken daily throughout the study

Secondary Outcomes

To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment(measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period))