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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01111331
Recruitment Status : Completed
First Posted : April 27, 2010
Results First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE April 26, 2010
First Posted Date  ICMJE April 27, 2010
Results First Submitted Date  ICMJE May 16, 2014
Results First Posted Date  ICMJE July 23, 2014
Last Update Posted Date July 23, 2014
Study Start Date  ICMJE May 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
  • 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. ]
    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. ]
    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 ]
    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 ]
    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 ]
    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 ]
    Maximum measured concentration of the analyte in plasma
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2010)
  • 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 ]
  • 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 ]
  • 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 ]
  • C(max) (maximum measured concentration of the analyte in plasma) [ Time Frame: 8 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
  • 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) ]
    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. ]
    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. ]
    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 ]
    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. ]
    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. ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2010)
  • 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 ]
  • time from dosing to the maximum concentration of the analyte in plasma [ Time Frame: 8 days ]
  • terminal rate constant in plasma [ Time Frame: 8 days ]
  • terminal half-life of the analyte in plasma [ Time Frame: 8 days ]
  • mean residence time of the analyte in the body after po administration [ Time Frame: 8 days ]
  • apparent clearance of the analyte in the plasma after extravascular administration [ Time Frame: 8 days ]
  • apparent volume of distribution during the terminal phase ¿z following an extravascular dose [ Time Frame: 8 days ]
  • concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose of BI 10773 [ Time Frame: 8 days ]
  • terminal half-life of the analyte in plasma at steady state [ Time Frame: 8 days ]
  • time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval [ Time Frame: 8 days ]
  • mean residence time of the analyte in the body at steady state after oral administration [ Time Frame: 8 days ]
  • apparent clearance of the analyte in the plasma after extravascular administration at steady state [ Time Frame: 8 days ]
  • apparent volume of distribution during the terminal phase at steady state following extravascular administration [ Time Frame: 8 days ]
  • Pharmacodynamics [ Time Frame: 8 days ]
  • Safety and tolerability [ Time Frame: 4 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers
Official Title  ICMJE 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)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2010)
18
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

Healthy male subjects

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01111331
Other Study ID Numbers  ICMJE 1245.18
2009-018088-29 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date June 2014

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