Phase 1
Completed N=72
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets
Healthy
Source: ClinicalTrials.gov NCT01975220 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin — 6430; 6430; 5690; 5850 nmol*h/L — p=<0.0001
Summary
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin & metformin and the single tablets of empagliflozin and metformin when administered singularly.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin |
6430; 6430; 5690; 5850; 7160; 7110 | <0.0001 sig |
| PRIMARY AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin |
6350; 6700; 13000; 13100; 10200; 10300 | 0.0256 sig |
| PRIMARY Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin |
886; 810; 559; 601; 1010; 963 | 0.0072 sig |
| PRIMARY Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin |
822; 851; 1180; 1070; 1300; 1330 | 0.0198 sig |
| SECONDARY AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin |
6510; 6490; 5800; 5970; 7240; 7180 | <0.0001 sig |
| SECONDARY AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin |
6490; 6790; 13200; 13200; 10500; 10400 | 0.0254 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 (NCT01975220). 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.