This is an open-label, randomised study to compare the similarity of a combination Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and fed conditions in healthy volunteers.
A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5.0 mg/850 mg) Relative to a 5.0 mg Dapagliflozin Tablet and an 850 mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
71
Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fasted state
single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fasted state
Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fed state
Research Site
London, United Kingdom
Area under the curve over the time (AUC)
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
AUC from time zero to the time of last quantifiable analyte concentration (AUC(0-t))
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Maximum concentration (Cmax)
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Time to reach maximum analyte concentration (tmax)
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Terminal rate constant (λz)
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Time of last quantifiable analyte concentration (tlast)
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
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single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fed state
Terminal half-life (t1/2)
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Observed maximum analyte concentration (Cmax)
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC)
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0 t))
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Elimination terminal half-life (t1/2)
No statistical analysis will be performed
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Safety profile description in term of Adverse Events
No statistical analysis will be performed
Time frame: from first dose in treatment period 1 up to 10 days after final dose
Safety profile description in term of Blood Pressure
No statistical analysis will be performed
Time frame: at screening, once daily during the residential period (5 days each) and up to 10 days after final dose
Safety profile description in term of Physical Examination
No statistical analysis will be performed
Time frame: at screening, Day -1 and Day 4 at Visits 2 to 5 and up to 10 days after final dose
Safety profile description in term of Electrocardiogram ECG
No statistical analysis will be performed
Time frame: at screening and up to 10 days after final dose
Safety profile description in term of Heart Rate
No statistical analysis will be performed
Time frame: at screening, once daily during the residential period (5 days each) and up to 10 days after final dose
Safety profile description in term of Safety Labs
No statistical analysis will be performed
Time frame: at screening, on Day -1 and Day 4 (72 hours post-dose) at Visits 2 to 5 and up to 10 days after final dose