Phase 1
Completed N=42
Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food
Healthy
Source: ClinicalTrials.gov NCT01189201 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) — 5990; 5720 nmol*h/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) |
5990; 5720 | — |
| PRIMARY Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72) |
264; 250 | — |
| PRIMARY Empagliflozin: Maximum Measured Concentration (Cmax) |
862; 803 | — |
| PRIMARY Linagliptin: Maximum Measured Concentration (Cmax) |
8.19; 7.49 | — |
| PRIMARY Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax) |
949; 583 | — |
| PRIMARY Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) |
6330; 5400 | — |
| PRIMARY Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax) |
8.97; 6.14 | — |
| PRIMARY Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72) |
275; 250 | — |
| PRIMARY Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax) |
802; 787 | — |
| PRIMARY Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) |
5740; 5490 | — |
| PRIMARY Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax) |
7.65; 7.93 | — |
| PRIMARY Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72) |
256; 247 | — |
| SECONDARY Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax) |
1.50; 1.25; 2.00; 1.50 | — |
| SECONDARY Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax) |
1.50; 1.75; 2.25; 1.50 | — |
| SECONDARY Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞) |
6060; 5800 | — |
| SECONDARY Linagliptin: Area Under the Curve 0 to Infinity (AUC0-∞) |
435; 410 | — |
| SECONDARY Empagliflozin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞) |
6410; 5500 | — |
| SECONDARY Linagliptin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞) |
453; 421 | — |
| SECONDARY Empagliflozin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞) |
5810; 5560 | — |
| SECONDARY Linagliptin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞) |
423; 393 | — |
| SECONDARY Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
healthy male and female subjects
Data sourced from ClinicalTrials.gov (NCT01189201). 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.