Phase 1
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
Bottom Line
View on ClinicalTrials.gov: NCT01242176 ↗Enrolled (actual)
24
Serious AEs
2.2%
Results posted
Jun 2014
Primary outcome: Primary: Area Under the Curve 0 to Infinity (AUC0-∞) — 5200; 5090 nmol*h/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 10773 XX (Trial Formulation 2) (Drug); BI 10773 (Final Formulation) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2010
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 | — |
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).
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.