Phase 1
Completed N=24
Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
Healthy
Source: ClinicalTrials.gov NCT01844531 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: AUC0-∞ for Empagliflozin — 2780; 2870; 1110; 1070 nmol*h/L — p=0.0000
Summary
The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high fat, high caloric meal.
The assessment of safety and tolerability will be an additional objective of this trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-∞ for Empagliflozin |
2780; 2870; 1110; 1070 | 0.0000 sig |
| PRIMARY AUC0-∞ for Metformin |
5590; 5820; 5960; 6190 | 0.0006 sig |
| PRIMARY Cmax for Empagliflozin |
294; 282; 109; 106 | 0.0000 sig |
| PRIMARY Cmax for Metformin |
686; 718; 693; 743 | 0.0001 sig |
| SECONDARY AUC0-tz for Empagliflozin |
2740; 2830; 1080; 1040 | 0.0000 sig |
| SECONDARY AUC0-tz for Metformin |
5480; 5720; 5820; 6110 | 0.0008 sig |
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
- Subjects must be able to understand and comply with study requirements
- Age 18 to 50 years
- Body mass index (BMI) 18.5 to 29.9 kg/m2
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01844531). 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.