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Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets

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ClinicalTrials.gov Identifier: NCT01844531
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high fat, high caloric meal.

The assessment of safety and tolerability will be an additional objective of this trial.


Condition or disease Intervention/treatment Phase
Healthy Drug: empagliflozin Drug: metformin (Glucophage®) Drug: empagliflozin and metformin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence of Empagliflozin/Metformin (500 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 : April 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FDC empagliflozin dose 1 and metformin
fix dose combination tablet after intake of a high fat, high caloric meal
Drug: empagliflozin and metformin
FDC tablet empagliflozin and metformin

Active Comparator: empagliflozin dose 1 + metformin tablets
single tablets after intake of a high fat, high caloric meal
Drug: empagliflozin
single tablet empagliflozin

Drug: metformin (Glucophage®)
single tablet metformin

Experimental: FDC empagliflozin dose 2 and metformin
fix dose combination tablet after intake of a high fat, high caloric meal
Drug: empagliflozin and metformin
FDC tablet empagliflozin and metformin

Active Comparator: empagliflozin dose 2 + metformin tablets
single tablets after intake of a high fat, high caloric meal
Drug: metformin (Glucophage®)
single tablet metformin

Drug: empagliflozin
single tablet empagliflozin




Primary Outcome Measures :
  1. AUC0−∞ for Empagliflozin [ Time Frame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake ]
    AUC0−∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Empagliflozin

  2. AUC0−∞ for Metformin [ Time Frame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake ]
    AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin

  3. Cmax for Empagliflozin [ Time Frame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake ]
    Cmax (maximum measured concentration of the analyte in plasma) for Empagliflozin

  4. Cmax for Metformin [ Time Frame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake ]
    Cmax (maximum measured concentration of the analyte in plasma) for Metformin


Secondary Outcome Measures :
  1. AUC0-tz for Empagliflozin [ Time Frame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake ]
    AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Empagliflozin

  2. AUC0-tz for Metformin [ Time Frame: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake ]
    AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Metformin



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
  2. Subjects must be able to understand and comply with study requirements
  3. Age 18 to 50 years
  4. Body mass index (BMI) 18.5 to 29.9 kg/m2

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): NCT01844531


Locations
Germany
1276.6.1 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: NCT01844531     History of Changes
Other Study ID Numbers: 1276.6
2012-000082-20 ( EudraCT Number: EudraCT )
First Posted: May 1, 2013    Key Record Dates
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015
Last Verified: June 2015

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