Phase 1
Completed N=27
Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
Source: ClinicalTrials.gov NCT01068717 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States — 10.54; 11.53; 12.71; 12.79 ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States |
10.54; 11.53; 12.71; 12.79 | — |
| PRIMARY Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States |
1058.19; 1044.70; 810.08; 811.94 | — |
| PRIMARY Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States |
6.16; 6.69; 5.99; 6.15; 11.05; 13.02 | — |
| PRIMARY 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 |
50.28; 51.60; 59.00; 58.94 | — |
| PRIMARY AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States |
8035.25; 7906.00; 7497.56; 7654.00 | — |
| PRIMARY AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States |
52.17; 53.73; 61.31; 60.88 | — |
| PRIMARY AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States |
8142.68; 8070.25; 7612.94; 7690.69 | — |
| PRIMARY 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 |
1.00; 0.75; 1.50; 1.00; 3.00; 3.00 | — |
| SECONDARY Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women, aged 18 to 55 years, inclusive
- Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
- Body Mass Index of 18 to 32 kg/m^2, inclusive
Exclusion Criteria
- 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
- History of allergy to DPP-4 inhibitors or related compounds
- History of allergy or intolerance to metformin or other similar acting agents
- Previous exposure to saxagliptin
- Exposure to metformin within 3 months pervious to study drug administration
- Estimated creatinine clearance of <80 mL/min using the Cockcroft Gault formula
Data sourced from ClinicalTrials.gov (NCT01068717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.