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Completed

NCT Number: NCT01211197

Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability

The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1276.5.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males and females according to the following criteria
  • Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

Exclusion criteria

  • Any finding of the medical examination (including Blood Pressure, Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease

Treatment and study plan

C: BI 10773 / metformin tablet

Drug

BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal

B: BI 10773 tablet and metformin tablet

Drug

BI 10773 and metformin single tablets, administered together in fasted state

A: BI 10773 / metformin tablet

Drug

BI 10773 / metformin fixed dose combination tablet in fasted state

Primary outcomes

  1. Empa: Area Under the Curve 0 to Infinity (AUC0-∞)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 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.

    Note the standard deviation is actually the coefficient of variation (CV).

  2. Empa: Maximum Measured Concentration (Cmax)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 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.

    Note the standard deviation is actually the CV.

  3. Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 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 metformin in plasma over the time interval from 0 extrapolated to infinity.

    Note the standard deviation is actually the CV.

  4. Metformin: Maximum Measured Concentration (Cmax)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Maximum measured concentration of metformin in plasma.

    Note the standard deviation is actually the CV.

Secondary outcomes

  1. Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 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 time of the last quantifiable data point.

    Note the standard deviation is actually the CV.

  2. Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 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 metformin in plasma over the time interval from 0 to the time of the last quantifiable data point.

    Note the standard deviation is actually the CV.

  3. Time to Maximum Measured Concentration (Tmax)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Time from dosing to the maximum concentration of the analyte in plasma.

    Note the standard deviation is actually the CV.

  4. Terminal Elimination Rate Constant in Plasma (λz)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Terminal elimination rate constant in plasma.

    Note the standard deviation is actually the CV.

  5. Terminal Half-life in Plasma (T1/2)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Terminal half-life of the analyte in plasma.

    Note the standard deviation is actually the CV.

  6. Mean Residence Time in the Body After Oral Administration (MRTpo)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Mean residence time of the analyte in the body after oral administration.

    Note the standard deviation is actually the CV.

  7. Apparent Clearance After Extravascular Administration (CL/F)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Apparent clearance of the analyte in the plasma after extravascular administration.

    Note the standard deviation is actually the CV.

  8. Apparent Volume of Distribution During the Terminal Phase (Vz/F)

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Apparent volume of distribution during the terminal phase (λz).

    Note the standard deviation is actually the CV.

  9. Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.

    Time frame: Drug administration up to 7 days after last drug administration, up to 8 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of a 12.5 mg BI 10773 / 1000 mg Metformin Fixed Dose Combination Tablet Compared With Its Monocomponents and Administered With and Without Food (an Open-label, Randomised, Single-dose, Three-way Crossover, Phase I Trial in Healthy Volunteers)

Important dates

Study start
2010
Primary completion
2010
First posted
Sep 29, 2010
Registry last updated
Aug 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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