To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and metformin, 1000-mg XR tablets administered together in both the fasted and fed states.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
112
Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day
Tablet, oral, 5 mg, once on Day 1 only, 1 day
Tablet, oral, 500 mg, once on Day 1 only, 1 day
Local Institution
Campinas, São Paulo, Brazil
Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
Time frame: Days 1, 2, and 3 of Periods 1 and 2
AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
AUC=Area under the concentration-time curve
Time frame: Days 1, 2, and 3 of Periods 1 and 2
AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
AUC=Area Under the Concentration-time Curve
Time frame: Days 1, 2, and 3 of Periods 1 and 2
Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Time frame: Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day
Tablet, oral, 1000 mg, once on Day 1 only, 1 day