Phase 1
Completed N=18
Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.
Healthy
Source: ClinicalTrials.gov NCT01451775 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Area Under the Curve 0 to Infinity (AUC0-∞) — 5380; 4520; 2280 nmol*h/L
Summary
Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve 0 to Infinity (AUC0-∞) |
5380; 4520; 2280 | — |
| PRIMARY Maximum Measured Concentration (Cmax) |
837; 523; 365 | — |
| SECONDARY Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator. |
0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01451775). 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.