Phase 1
Completed N=24
Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers
Healthy
Source: ClinicalTrials.gov NCT01242176 ↗
Enrolled (actual)
24
Serious AEs
2.2%
Results posted
Jun 2014
Primary outcomePrimary: Area Under the Curve 0 to Infinity (AUC0-∞) — 5200; 5090 nmol*h/L
Summary
The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve 0 to Infinity (AUC0-∞) |
5200; 5090 | — |
| PRIMARY Maximum Measured Concentration (Cmax) |
764; 764 | — |
| SECONDARY Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) |
5140; 5030 | — |
Eligibility Criteria
Inclusion criteria
Healthy male and female subjects
Data sourced from ClinicalTrials.gov (NCT01242176). 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.