Phase 1
Completed N=36
Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets
Healthy
Source: ClinicalTrials.gov NCT01672788 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Empa: Area Under the Curve 0 to Infinity (AUC0-∞) — 2560; 2530; 986; 968 nmol*h/L
Summary
The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Empa: Area Under the Curve 0 to Infinity (AUC0-∞) |
2560; 2530; 986; 968 | — |
| PRIMARY Metformin: Area Under the Curve 0 to Infinity (AUC0-∞) |
8640; 8450; 8520; 8560 | — |
| PRIMARY Empa: Maximum Measured Concentration (Cmax) |
266; 258; 103; 101 | — |
| PRIMARY Metformin: Maximum Measured Concentration (Cmax) |
1080; 1080; 1090; 1100 | — |
| SECONDARY Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) |
2520; 2490; 963; 946 | — |
| SECONDARY Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) |
8370; 8190; 8280; 8320 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01672788). 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.