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Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets

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ClinicalTrials.gov Identifier: NCT01672788
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.

Condition or disease Intervention/treatment Phase
Healthy Drug: Empagliflozin Drug: Empagliflozin + Metformin Drug: Metformin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence of Empagliflozin/Metformin (850 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open-label, Randomised, Single-dose, Four-way Crossover Study)
Study Start Date : August 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Test 1
fixed dose combination tablet
Drug: Empagliflozin + Metformin
fixed dose combination tablet (low)
Active Comparator: Reference 1
empagliflozin tablets and metformin tablet
Drug: Empagliflozin
empagliflozin tablets and metformin tablet
Drug: Metformin
empagliflozin tablets and metformin tablet
Experimental: Test 2
fixed dose combination tablet
Drug: Empagliflozin + Metformin
fixed dose combination tablet (low)
Active Comparator: Reference 2
empagliflozin tablet and metformin tablet
Drug: Metformin
empagliflozin tablet and metformin tablet
Drug: Empagliflozin
empagliflozin tablet and metformin tablet



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, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.

    In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.


  2. Metformin: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.

    In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.


  3. Empa: Maximum Measured Concentration (Cmax) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]

    Maximum measured concentration of the analyte in plasma, per period.

    In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.


  4. Metformin: Maximum Measured Concentration (Cmax) [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]

    Maximum measured concentration of the analyte in plasma, per period.

    In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.



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, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.

    In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.


  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, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.

    In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions


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): NCT01672788


Locations
Germany
1276.7.1 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: NCT01672788     History of Changes
Other Study ID Numbers: 1276.7
2012-002277-65 ( EudraCT Number: EudraCT )
First Posted: August 27, 2012    Key Record Dates
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Empagliflozin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs