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Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets

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ClinicalTrials.gov Identifier: NCT01975220
Recruitment Status : Completed
First Posted : November 3, 2013
Results First Posted : March 8, 2017
Last Update Posted : March 8, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin & metformin and the single tablets of empagliflozin and metformin when administered singularly.

Condition or disease Intervention/treatment Phase
Healthy Drug: Empagliflozin/Metformin XR, FDC Drug: Empagliflozin/Metformin XR FDC Drug: 25 mg Empagliflozin/1000 mg Metformin XR, FDC Drug: 1 tablet Empagliflozin/2 tablets Metformin XR Drug: 1 tablet Empagliflozin/3 tablets Metformin XR Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (25mg/1000mg and 12.5mg/750mg) of Empagliflozin/Metformin Extended Release Compared With the Free Combination of Empagliflozin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)
Study Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: High dose, fasted
1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions
 Drug: 25 mg Empagliflozin/1000 mg Metformin XR, FDC
Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet

Drug: 1 tablet Empagliflozin/2 tablets Metformin XR
Active Comparator: 1x empagliflozin/2x metformin XR tablets
Experimental: High dose, fed
1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions
 Drug: Empagliflozin/Metformin XR, FDC
Experimental: high dose empagliflozin/metformin XR, FDC tablet

Drug: 1 tablet Empagliflozin/2 tablets Metformin XR
Active Comparator: 1x empagliflozin/2x metformin XR tablets
Experimental: Low dose, fasted
2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions
 Drug: Empagliflozin/Metformin XR FDC
Experimental: low dose empagliflozin/metformin XR, FDC tablet

Drug: 1 tablet Empagliflozin/3 tablets Metformin XR
Active Comparator: 1x empagliflozin/3x metformin XR tablets


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 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 (AUC 0-tz); Empagliflozin

  2. AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration ]
    AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin

  3. Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration ]
    Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin

  4. Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration ]
    Cmax (maximum measured concentration of the analyte in plasma); Metformin


Secondary Outcome Measures :
  1. AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration ]
    AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin

  2. AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin [ Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration ]
    AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin


Eligibility Criteria
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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 males or females
  2. Age 18-50 years (incl)
  3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl)
  4. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

Any deviation from healthy condition

Contacts and Locations
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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): NCT01975220


Locations
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United States, Texas
1276.13.1 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01975220    
Other Study ID Numbers: 1276.13
First Posted: November 3, 2013    Key Record Dates
Results First Posted: March 8, 2017
Last Update Posted: March 8, 2017
Last Verified: August 2016
Additional relevant MeSH terms:
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Metformin
Empagliflozin
Hypoglycemic Agents
 Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action