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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
15
Tablets, Oral, 10 mg, Single Dose
Tablets, Oral, 1000 mg, Single Dose
Tablets, Oral, 1000 mg, Single Dose
Ppd Development, Lp
Austin, Texas, United States
Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone
Time frame: 48 hours post-dose
Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments)
Time frame: 15 timepoints in 48 hours time interval
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