Diabetes Mellitus, Type 2
Conditions
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
Interventions
DRUGDapagliflozin
Tablets, Oral, 20 mg, once daily, single dose
DRUGGlimepiride
Tablets, Oral, 4 mg, once daily, single dose
DRUGDapagliflozin + Glimepiride
Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together | plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Recorded adverse events | for 72 hours after each administered dose |
Countries
Argentina
Outcome results
None listed