Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01111331
First received: April 26, 2010
Last updated: June 25, 2014
Last verified: June 2014

April 26, 2010
June 25, 2014
May 2010
July 2010   (final data collection date for primary outcome measure)
  • Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin. ] [ Designated as safety issue: No ]

    Area under the plasma concentration-time curve for the dosing interval τ at steady state

    In addition to the specified time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin.

  • Empagliflozin: Maximum Measured Concentration at Steady State(Cmax,ss) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin. ] [ Designated as safety issue: No ]

    Maximum measured plasma concentration of empagliflozin (empa) for the dosing interval τ at steady state.

    In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin.

  • Warfarin R-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.
  • Warfarin R-enantiomers: Maximum Measured Concentration (Cmax) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Maximum measured concentration of the analyte in plasma.
  • Warfarin S-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.
  • Warfarin S-enantiomers: Maximum Measured Concentration (Cmax) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Maximum measured concentration of the analyte in plasma
  • C(max) (maximum measured concentration of the analyte in plasma) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • AUC(tau,ss) (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) of BI 10773. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • C(max,ss) (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau) of BI 10773. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • AUC(0-infinity) (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01111331 on ClinicalTrials.gov Archive Site
  • Empagliflozin: Plasma Concentration 24 Hours After Administration of Dose (C24,N) [ Time Frame: 24 hours after dose 4 or 6 respectively (day 5 and day 7) ] [ Designated as safety issue: No ]
    Plasma concentration of empagliflozin (empa) measured 24 hours after administration of the fourth dose (Cpre,5) and after the sixth dose (Cpre,7).
  • Empagliflozin: Terminal Rate Constant at Steady State (λz,ss) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin. ] [ Designated as safety issue: No ]

    Terminal rate constant of empagliflozin (empa) in plasma at steady state.

    In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin.

  • Empagliflozin: Terminal Half-life at Steady State (t1/2,ss) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin. ] [ Designated as safety issue: No ]

    Terminal half-life of empagliflozin (empa) in plasma at steady state.

    In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin.

  • Empagliflozin: Time to Maximum Plasma Concentration at Steady State (Tmax,ss) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin ] [ Designated as safety issue: No ]

    Time from last dosing to maximum plasma concentration at steady state over a uniform dosing interval τ.

    In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin.

  • Empagliflozin: Mean Residence Time at Steady State After Oral Administration (MRTpo,ss) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin. ] [ Designated as safety issue: No ]

    Mean residence time of empagliflozin (empa) in the body at steady state after oral administration.

    In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin.

  • Empagliflozin: Apparent Clearance at Steady State (CL/F,ss) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin. ] [ Designated as safety issue: No ]

    Apparent clearance in plasma after extravascular administration at steady state.

    In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin.

  • Empagliflozin: Apparent Volume of Distribution Following Extravascular Administration (Vz/F,ss) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin ] [ Designated as safety issue: No ]

    Apparent volume of distribution during the terminal phase at steady state following extravascular administration.

    In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin.

  • Warfarin R-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve from time of dosing to time of last measurable data point.
  • Warfarin R-enantiomers: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Time from dosing until maximum plasma concentration is reached
  • Warfarin R-enantiomers: Terminal Rate Constant (λz) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Terminal rate constant in plasma
  • Warfarin R-enantiomers: Terminal Half-life (t1/2) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Terminal half-life of the analyte in plasma
  • Warfarin R-enantiomers: Mean Residence Time After Oral Administration (MRTpo) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Mean residence time of the analyte in the body after oral administration
  • Warfarin R-enantiomers: Apparent Clearance After Extravascular Administration (CL/F) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Apparent clearance in plasma after extravascular administration
  • Warfarin R-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Apparent volume of distribution during the terminal phase λz following extravascular administration
  • Warfarin S-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve from time of dosing to time of last measurable data point.
  • Warfarin S-enantiomers: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Time from dosing until maximum plasma concentration is reached
  • Warfarin S-enantiomers: Terminal Rate Constant (λz) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Terminal rate constant in plasma
  • Warfarin S-enantiomers: Terminal Half-life (t1/2) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Terminal half-life of the analyte in plasma
  • Warfarin S-enantiomers: Mean Residence Time After Oral Administration (MRTpo) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Mean residence time of the analyte in the body after oral administration
  • Warfarin S-enantiomers: Apparent Clearance After Extravascular Administration (CL/F) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Apparent clearance in plasma after extravascular administration
  • Warfarin S-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F) [ Time Frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Apparent volume of distribution during the terminal phase λz following extravascular administration
  • Warfarin: Peak International Normalised Ratio (INRmax) [ Time Frame: 0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Peak international normalised ratio for warfarin, measured as the maximum INR over time.
  • Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point (INR AUEC0-tz) [ Time Frame: 0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Area under the concentration time curve of the INR measurements over the time interval from 0 to the time of the last quantifiable data point.
  • Warfarin: Peak International Normalised Ratio Adjusted to Baseline (INRmax,Base) [ Time Frame: 0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Peak international normalised ratio for warfarin adjusted for baseline value (before any trial drug administration) of peak international normalised ratio
  • Warfarin: Peak Prothrombin Time (PTmax) [ Time Frame: 0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Peak prothrombin time
  • Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (INR AUEC0-tz,Base) [ Time Frame: 0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Area under the INR-time curve from time of dosing to time of last measurable data point adjusted for baseline value (before any trial drug administration) of area under the INR-time curve
  • Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point (PT AUEC0-tz) [ Time Frame: 0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Area under the PT-time curve from time of dosing to time of last measurable data point
  • Warfarin: Peak Prothrombin Time Adjusted to Baseline (PTmax,Base) [ Time Frame: 0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Peak prothrombin time adjusted for baseline value (before any trial drug administration) of peak prothrombin
  • Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (PT AUEC0-tz,Base) [ Time Frame: 0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin ] [ Designated as safety issue: No ]
    Area under the PT-time curve from time of dosing to time of last measurable data point adjusted for baseline value (before any trial drug administration) of area under the PT-time curve
  • Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by Investigator [ Time Frame: Drug administration until beginning of next sequence/end of trial, 35 days ] [ Designated as safety issue: No ]
    Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
  • area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • time from dosing to the maximum concentration of the analyte in plasma [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • terminal rate constant in plasma [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • terminal half-life of the analyte in plasma [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • mean residence time of the analyte in the body after po administration [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • apparent clearance of the analyte in the plasma after extravascular administration [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • apparent volume of distribution during the terminal phase ¿z following an extravascular dose [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose of BI 10773 [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • terminal half-life of the analyte in plasma at steady state [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • mean residence time of the analyte in the body at steady state after oral administration [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • apparent clearance of the analyte in the plasma after extravascular administration at steady state [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • apparent volume of distribution during the terminal phase at steady state following extravascular administration [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers
Relative Bioavailability of Both BI 10773 and Warfarin and Pharmacodynamics of Warfarin After Co-administration Compared to Multiple Oral Doses of BI 10773 (25 mg Once Daily) and a Single Oral Dose of Warfarin (25 mg) Alone in Healthy Male Volunteers (an Open-label, Crossover, Clinical Phase I Study)

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: BI 10773 25 mg
    25 mg BI 10773 qd for 5 days
  • Drug: Warfarin 25 mg
    25 mg Warfarin single dose
  • Drug: BI 10773 25 mg
    25 mg BI 10773 qd for 12 days
  • Drug: Warfarin
    25 mg warfarin single dose with and without 50 mg BI 10773
  • Experimental: BI 10773 25 mg
    1 tablet 25 mg BI 10773 qd for 5 days
    Intervention: Drug: BI 10773 25 mg
  • Experimental: BI 10773 25 mg + Warfarin 25 mg
    1 tablet 25 mg BI 10773 qd for 7 days plus 5 tablets 5 mg warfarin single dose
    Interventions:
    • Drug: BI 10773 25 mg
    • Drug: Warfarin 25 mg
  • Active Comparator: Warfarin 25 mg
    5 tablets 5 mg warfarin single dose
    Intervention: Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Not Provided
July 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

Healthy male subjects

Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01111331
1245.18, 2009-018088-29
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP