Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
With
Bristol-Myers Squibb
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
