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

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211197
• Other study ID #: 1276.5
• Secondary ID: 2010-018589-22
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2010
• Last updated: July 27, 2015
• Start date: October 2010

Study information

• Verified date: July 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• C: BI 10773 / metformin tablet
BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal
• B: BI 10773 tablet and metformin tablet
BI 10773 and metformin single tablets, administered together in fasted state
• A: BI 10773 / metformin tablet
BI 10773 / metformin fixed dose combination tablet in fasted state

Locations

Country	Name	City	State
Germany	1276.5.1 Boehringer Ingelheim Investigational Site	Biberach

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Empa: Area Under the Curve 0 to Infinity (AUC0-8)	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).	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	No
Primary	Empa: Maximum Measured Concentration (Cmax)	Maximum measured concentration of empagliflozin (empa) in plasma.; Note the standard deviation is actually the CV.	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	No
Primary	Metformin: Area Under the Curve 0 to Infinity (AUC0-8)	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.	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	No
Primary	Metformin: Maximum Measured Concentration (Cmax)	Maximum measured concentration of metformin in plasma.; Note the standard deviation is actually the CV.	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	No
Secondary	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.	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	No
Secondary	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.	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	No
Secondary	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.	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	No
Secondary	Terminal Elimination Rate Constant in Plasma (?z)	Terminal elimination rate constant in plasma.; Note the standard deviation is actually the CV.	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	No
Secondary	Terminal Half-life in Plasma (T1/2)	Terminal half-life of the analyte in plasma.; Note the standard deviation is actually the CV.	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	No
Secondary	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.	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	No
Secondary	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.	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	No
Secondary	Apparent Volume of Distribution During the Terminal Phase (Vz/F)	Apparent volume of distribution during the terminal phase (?z).; Note the standard deviation is actually the CV.	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	No
Secondary	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.	Drug administration up to 7 days after last drug administration, up to 8 days	No

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