Phase 1
Completed N=18
Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT01111331 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss) — 4580.38; 4621.37 nmol*h/L
Summary
The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss) |
4580.38; 4621.37 | — |
| PRIMARY Empagliflozin: Maximum Measured Concentration at Steady State(Cmax,ss) |
759.96; 764.82 | 0.0021 sig |
| PRIMARY Warfarin R-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞) |
63585.71; 62626.35 | — |
| PRIMARY Warfarin R-enantiomers: Maximum Measured Concentration (Cmax) |
1404.07; 1374.40 | 0.0001 sig |
| PRIMARY Warfarin S-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞) |
37493.28; 35949.84 | — |
| PRIMARY Warfarin S-enantiomers: Maximum Measured Concentration (Cmax) |
1441.66; 1425.56 | 0.0001 sig |
| SECONDARY Empagliflozin: Plasma Concentration 24 Hours After Administration of Dose (C24,N) |
40.8; NA; NA; 41.6 | — |
| SECONDARY Empagliflozin: Terminal Rate Constant at Steady State (λz,ss) |
0.10; 0.10 | — |
| SECONDARY Empagliflozin: Terminal Half-life at Steady State (t1/2,ss) |
6.67; 7.07 | — |
| SECONDARY Empagliflozin: Time to Maximum Plasma Concentration at Steady State (Tmax,ss) |
1.50; 1.00 | — |
| SECONDARY Empagliflozin: Mean Residence Time at Steady State After Oral Administration (MRTpo,ss) |
8.64; 9.08 | — |
| SECONDARY Empagliflozin: Apparent Clearance at Steady State (CL/F,ss) |
187; 183 | — |
| SECONDARY Empagliflozin: Apparent Volume of Distribution Following Extravascular Administration (Vz/F,ss) |
108; 112 | — |
| SECONDARY Warfarin R-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz) |
58556.93; 57911.05 | — |
| SECONDARY Warfarin R-enantiomers: Time to Maximum Plasma Concentration (Tmax) |
0.84; 1.00 | — |
| SECONDARY Warfarin R-enantiomers: Terminal Rate Constant (λz) |
0.0147; 0.0151 | — |
| SECONDARY Warfarin R-enantiomers: Terminal Half-life (t1/2) |
47.1; 45.8 | — |
| SECONDARY Warfarin R-enantiomers: Mean Residence Time After Oral Administration (MRTpo) |
62.9; 61.2 | — |
| SECONDARY Warfarin R-enantiomers: Apparent Clearance After Extravascular Administration (CL/F) |
6.55; 6.65 | — |
| SECONDARY Warfarin R-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F) |
26.7; 26.4 | — |
| SECONDARY Warfarin S-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz) |
36386.49; 34962.95 | — |
| SECONDARY Warfarin S-enantiomers: Time to Maximum Plasma Concentration (Tmax) |
0.68; 0.84 | — |
| SECONDARY Warfarin S-enantiomers: Terminal Rate Constant (λz) |
0.0187; 0.0189 | — |
| SECONDARY Warfarin S-enantiomers: Terminal Half-life (t1/2) |
37.0; 36.7 | — |
| SECONDARY Warfarin S-enantiomers: Mean Residence Time After Oral Administration (MRTpo) |
40.8; 38.9 | — |
| SECONDARY Warfarin S-enantiomers: Apparent Clearance After Extravascular Administration (CL/F) |
11.1; 11.6 | — |
| SECONDARY Warfarin S-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F) |
35.6; 36.8 | — |
| SECONDARY Warfarin: Peak International Normalised Ratio (INRmax) |
1.76; 1.53 | — |
| SECONDARY Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point (INR AUEC0-tz) |
202.54; 178.08 | — |
| SECONDARY Warfarin: Peak International Normalised Ratio Adjusted to Baseline (INRmax,Base) |
0.69; 0.69 | — |
| SECONDARY Warfarin: Peak Prothrombin Time (PTmax) |
20.17; 18.07 | — |
| SECONDARY Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (INR AUEC0-tz,Base) |
32.42; 36.30 | — |
| SECONDARY Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point (PT AUEC0-tz) |
2508.34; 2281.54 | — |
| SECONDARY Warfarin: Peak Prothrombin Time Adjusted to Baseline (PTmax,Base) |
6.69; 6.51 | — |
| SECONDARY Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (PT AUEC0-tz,Base) |
419.24; 354.97 | — |
| SECONDARY Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by Investigator |
0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
Healthy male subjects
Data sourced from ClinicalTrials.gov (NCT01111331). 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.