Phase 1
Completed N=72
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets
Healthy
Source: ClinicalTrials.gov NCT02106923 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin — 2630; 2710; 2720; 2710 nmol*h/L — p=<0.0001
Summary
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin & metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin |
2630; 2710; 2720; 2710; 2790; 2680 | <0.0001 sig |
| PRIMARY AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin |
7020; 7170; 13500; 13200; 9860; 10100 | 0.0011 sig |
| PRIMARY Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin |
377; 395; 273; 277; 396; 381 | <0.0001 sig |
| PRIMARY Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin |
975; 964; 1110; 1200; 1220; 1270 | 0.0027 sig |
| SECONDARY AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin |
2680; 2760; 2790; 2770; 2840; 2740 | <0.0001 sig |
| SECONDARY AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin |
7480; 7360; 13900; 13600; 10500; 10900 | 0.0008 sig |
Eligibility Criteria
Inclusion criteria
- Healthy males or females
- Age 18-50 years (incl.)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
- Subjects must be able to understand and comply with study requirements
Exclusion criteria
Any deviation from healthy condition
Data sourced from ClinicalTrials.gov (NCT02106923). 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.