ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01211197
Recruitment Status : Completed
First Posted : September 29, 2010
Results First Posted : August 21, 2015
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: C: BI 10773 / metformin tablet Drug: B: BI 10773 tablet and metformin tablet Drug: A: BI 10773 / metformin tablet Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : October 2010
Actual Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
3 treatments will be investigated in randomized order
Drug: A: BI 10773 / metformin tablet
BI 10773 / metformin fixed dose combination tablet in fasted state

Experimental: B
3 treatments will be investigated in randomized order
Drug: B: BI 10773 tablet and metformin tablet
BI 10773 and metformin single tablets, administered together in fasted state

Experimental: C
3 treatments will be investigated in randomized order
Drug: C: BI 10773 / metformin tablet
BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211197


Locations
Germany
1276.5.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01211197     History of Changes
Other Study ID Numbers: 1276.5
2010-018589-22 ( EudraCT Number: EudraCT )
First Posted: September 29, 2010    Key Record Dates
Results First Posted: August 21, 2015
Last Update Posted: August 21, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs