Back to resultsBioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
C: BI 10773 / metformin tablet
B: BI 10773 tablet and metformin tablet
A: BI 10773 / metformin tablet
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
- 1276.5.1 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A
B
C
Arm Description
3 treatments will be investigated in randomized order
3 treatments will be investigated in randomized order
3 treatments will be investigated in randomized order
Outcomes
Primary Outcome Measures
Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
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).
Empa: Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagliflozin (empa) in plasma.
Note the standard deviation is actually the CV.
Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)
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.
Metformin: Maximum Measured Concentration (Cmax)
Maximum measured concentration of metformin in plasma.
Note the standard deviation is actually the CV.
Secondary Outcome Measures
Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
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.
Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
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.
Time to Maximum Measured Concentration (Tmax)
Time from dosing to the maximum concentration of the analyte in plasma.
Note the standard deviation is actually the CV.
Terminal Elimination Rate Constant in Plasma (λz)
Terminal elimination rate constant in plasma.
Note the standard deviation is actually the CV.
Terminal Half-life in Plasma (T1/2)
Terminal half-life of the analyte in plasma.
Note the standard deviation is actually the CV.
Mean Residence Time in the Body After Oral Administration (MRTpo)
Mean residence time of the analyte in the body after oral administration.
Note the standard deviation is actually the CV.
Apparent Clearance After Extravascular Administration (CL/F)
Apparent clearance of the analyte in the plasma after extravascular administration.
Note the standard deviation is actually the CV.
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Apparent volume of distribution during the terminal phase (λz).
Note the standard deviation is actually the CV.
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01211197
Brief Title
Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability
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 Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
3 treatments will be investigated in randomized order
Arm Title
B
Arm Type
Experimental
Arm Description
3 treatments will be investigated in randomized order
Arm Title
C
Arm Type
Experimental
Arm Description
3 treatments will be investigated in randomized order
Intervention Type
Drug
Intervention Name(s)
C: BI 10773 / metformin tablet
Intervention Description
BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal
Intervention Type
Drug
Intervention Name(s)
B: BI 10773 tablet and metformin tablet
Intervention Description
BI 10773 and metformin single tablets, administered together in fasted state
Intervention Type
Drug
Intervention Name(s)
A: BI 10773 / metformin tablet
Intervention Description
BI 10773 / metformin fixed dose combination tablet in fasted state
Primary Outcome Measure Information:
Title
Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
Description
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).
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
Title
Empa: Maximum Measured Concentration (Cmax)
Description
Maximum measured concentration of empagliflozin (empa) in plasma.
Note the standard deviation is actually the CV.
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
Title
Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)
Description
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.
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
Title
Metformin: Maximum Measured Concentration (Cmax)
Description
Maximum measured concentration of metformin in plasma.
Note the standard deviation is actually the CV.
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
Secondary Outcome Measure Information:
Title
Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Description
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.
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
Title
Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Description
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.
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
Title
Time to Maximum Measured Concentration (Tmax)
Description
Time from dosing to the maximum concentration of the analyte in plasma.
Note the standard deviation is actually the CV.
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
Title
Terminal Elimination Rate Constant in Plasma (λz)
Description
Terminal elimination rate constant in plasma.
Note the standard deviation is actually the CV.
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
Title
Terminal Half-life in Plasma (T1/2)
Description
Terminal half-life of the analyte in plasma.
Note the standard deviation is actually the CV.
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
Title
Mean Residence Time in the Body After Oral Administration (MRTpo)
Description
Mean residence time of the analyte in the body after oral administration.
Note the standard deviation is actually the CV.
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
Title
Apparent Clearance After Extravascular Administration (CL/F)
Description
Apparent clearance of the analyte in the plasma after extravascular administration.
Note the standard deviation is actually the CV.
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
Title
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Description
Apparent volume of distribution during the terminal phase (λz).
Note the standard deviation is actually the CV.
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
Title
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.
Description
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
Drug administration up to 7 days after last drug administration, up to 8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1276.5.1 Boehringer Ingelheim Investigational Site
City
Biberach
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability
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