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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT01211197
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Study Start: 2010-10
• Primary Completion: 2010-12
• Results First Submitted: 2015-06-26
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-27
• Last Update Submitted: 2015-07-27
• Results First Posted: 2015-08-21
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Empa: Area Under the Curve 0 to Infinity (AUC0-∞)	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).
Empa: Maximum Measured Concentration (Cmax)	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.
Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)	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.
Metformin: Maximum Measured Concentration (Cmax)	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

Name	Time	Method
Terminal Elimination Rate Constant in Plasma (λz)	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.
Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	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.
Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	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.
Time to Maximum Measured Concentration (Tmax)	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.
Terminal Half-life in Plasma (T1/2)	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.
Mean Residence Time in the Body After Oral Administration (MRTpo)	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.
Apparent Clearance After Extravascular Administration (CL/F)	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.
Apparent Volume of Distribution During the Terminal Phase (Vz/F)	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.
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.	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.

Trial Locations

Locations (1)

1276.5.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany