Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.
Interventions
DRUGDapagliflozin
Tablets, Oral, 10 mg, Single Dose
DRUGMetformin XR
Tablets, Oral, 1000 mg, Single Dose
DRUGGlucophage
Tablets, Oral, 1000 mg, Single Dose
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women ages 18 to 45 inclusive * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2
Exclusion criteria
* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product * Any significant acute or chronic medical illness * Current or recent (within 3 months) gastrointestinal disease * Any major surgery within 4 weeks of study drug administration * Glucosuria at screening * Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN) * Presence of edema on physical exam * History of diabetes mellitus * History of heart failure * History of renal insufficiency * History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months * History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections * Estimated creatinine clearance (ClCR) of \< 80 mL/min using the Cockcroft Gault formula * History of allergy or intolerance to metformin or other similar agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone | 48 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments) | 15 timepoints in 48 hours time interval |
Countries
United States
Outcome results
None listed