To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
27
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
Ppd Development, Lp
Austin, Texas, United States
Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week
Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Time frame: Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4
Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results
Clinically significant was determined by the investigator. Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count. Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase. Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH.
Time frame: At screening visit, at Day -1 of Periods 1 through 4, and at discharge
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results
Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.
Time frame: At screening visit, Day -1 of Period 1, and at study discharge
Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate
Clinically significant was determined by the investigator. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.
Time frame: At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.