Phase 1
Completed N=112
Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
Source: ClinicalTrials.gov NCT01365091 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets — 713; 654; 1177; 1077 μg/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets |
713; 654; 1177; 1077; 678; 577 | — |
| PRIMARY 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 |
5816; 5071; 8174; 9628; 5386; 4701 | — |
| PRIMARY 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 |
5877; 5127; 8338; 9731; 5443; 4754 | — |
| SECONDARY Number of Participants With Death as Outcome and Serious Adverse Events (SAEs) |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Healthy men and women
- women of childbearing potential who are using acceptable method of contraception
- Women who are not pregnant or nursing
- Body Mass Index (BMI) of 18 to 29.9 kg/m^2, inclusive. BMI=weight(kg)/height(m)^2.
Key Exclusion Criteria
- Any significant acute or chronic medical illness.
- History of gastrointestinal (GI) disease
- Major surgery within 4 weeks of study drug administration
- Any GI surgery that could impact study drug absorption
- Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within the 6 months of study drug administration.
- Blood transfusion within 3 months of study drug administration for women and within 2 months for men
- Inability to be venipunctured and/or tolerate venous access
- Current smoker or recent (within 1 month) history of regular tobacco use
- Recent (within 6 months of study drug administration) drug or alcohol abuse
- Participation in a bioequivalence study within the last 6 months of study drug administration
- Estimated creatinine clearance of <80 mL/min using Cockcroft-Gault formula
- History of allergy to drug class or related compounds
- History of allergy to metformin or other similar acting agents
- History of any significant drug allergy
Data sourced from ClinicalTrials.gov (NCT01365091). 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.