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Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189201
First Posted: August 26, 2010
Last Update Posted: March 19, 2015
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
August 25, 2010
August 26, 2010
March 10, 2015
March 19, 2015
March 19, 2015
August 2010
November 2010   (Final data collection date for primary outcome measure)
  • Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Empagliflozin: Maximum Measured Concentration (Cmax) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Maximum measured concentration of empagliflozin (empa) in plasma.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Linagliptin: Maximum Measured Concentration (Cmax) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Maximum measured concentration of linagliptin in plasma.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Maximum measured concentration of empagliflozin (empa) in plasma, comparing fed with fasted.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Maximum measured concentration of linagliptin in plasma.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Maximum measured concentration of empagliflozin (empa) in plasma.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Maximum measured concentration of linagliptin in plasma.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • maximum measured concentration of the analyte in plasma for BI 10773 and linagliptin [ Time Frame: 4 days ]
  • area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours for linagliptin [ Time Frame: 4 days ]
  • area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration for BI 10773 [ Time Frame: 4 days ]
Complete list of historical versions of study NCT01189201 on ClinicalTrials.gov Archive Site
  • Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]
    Time from last dosing to the maximum measured concentration of empagliflozin (empa) in plasma.
  • Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]
    Time from last dosing to the maximum measured concentration of linagliptin in plasma
  • Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Linagliptin: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Empagliflozin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Linagliptin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Empagliflozin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Linagliptin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

    Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.

    In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  • Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator [ Time Frame: Drug administration until next treatment period/end-of-study examination, up to 36 days ]
    Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event was until the end-of-study examination.
  • time from last dosing to the maximum measured concentration of each analyte in plasma for BI 10773 and linagliptin [ Time Frame: 4 days ]
  • area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for BI 10773 and linagliptin [ Time Frame: 4 days ]
  • Additional pharmacokinetic parameters will be calculated as appropriate [ Time Frame: 4 days ]
  • Physical examination [ Time Frame: 2 days ]
  • Vital signs (blood pressure, pulse rate) [ Time Frame: 2 days ]
  • 12-lead electrocardiogram [ Time Frame: 2 days ]
  • Clinical laboratory tests (haematology, clinical chemistry and urinalysis) [ Time Frame: 3 days ]
  • Adverse events [ Time Frame: 5 days ]
  • Assessment of tolerability by investigator [ Time Frame: 5 days ]
Not Provided
Not Provided
 
Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food
Relative Bioavailability Investigations of a 25 mg BI 10773 / 5 mg Linagliptin Fixed Dose Combination (FDC) Tablet (Formulation A1) Including the Comparison With Its Mono-components, the Comparison With a Second FDC Tablet (Formulation A3), and the Investigation of Food (an Open-label, Randomised, Single Dose, Crossover, Phase I Trial in Healthy Male and Female Volunteers)

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • Drug: BI 10773/linagliptin
    medium single dose of BI 10773/linagliptin FDC (Formulation A1)
  • Drug: BI 10773/linagliptin
    medium single dose of BI 10773/linagliptin FDC (Formulation A3)
  • Drug: BI 10773/linagliptin SID
    medium single dose of mono components BI 10773/linagliptin
  • Drug: BI 10773/linagliptin FDC
    medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal
  • Experimental: BI 10773/linagliptin FDC SID
    medium single dose ofBI 10773/linagliptin FDC (Formulation A1)
    Intervention: Drug: BI 10773/linagliptin
  • Experimental: BI 10773/linagliptin SID
    medium single dose of mono components BI 10773/linagliptin
    Intervention: Drug: BI 10773/linagliptin SID
  • Experimental: BI 10773/linagliptin FDC
    medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal
    Intervention: Drug: BI 10773/linagliptin FDC
  • Experimental: BI 10773/linagliptin
    medium single dose of BI 10773/linagliptin FDC (Formulation A3)
    Intervention: Drug: BI 10773/linagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Not Provided
November 2010   (Final data collection date for primary outcome measure)

Inclusion criteria:

healthy male and female subjects

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01189201
1275.3
2010-019211-38 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2015

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