Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food
Summary
The primary objective of the current study is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test) compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference), both in the fasting state. All 42 subjects entered are planned to be included in this comparison. The secondary objective is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet after administration of a standardised high fat, high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the 42 subjects entered 18 subjects are planned to be included in this comparison. An additional objective is to investigate the relative bioavailability of a second formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned to be included in this comparison.
Timeline
- Start
- 2010-08
- Primary completion
- 2010-11
- Completion
- —
Outcome
Mixed primary results
paper In all three comparisons, the 90% confidence intervals for the ratios of AUCs were within the standard acceptance range (80 - 125%) for bioequivalence. PMID 28290274 ↗
registry Geometric Mean Ratio 61.41 (90% CI 54.10 to 69.71); ANOVA NCT01189201 ↗
paper Empagliflozin and linagliptin both showed reductions in Cmax after food compared with the fasted state PMID 28290274 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 25 mg | — |
| Subject | Linagliptin | Unknown | 5 mg | — |
Indications
No indication recorded.