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Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

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ClinicalTrials.gov Identifier: NCT01811953
Recruitment Status : Completed
First Posted : March 15, 2013
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence of Empagliflozin/Metformin Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed and Fasted Conditions (an Open-label, Randomised, Single-dose, Crossover Study)
Study Start Date : March 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Empagliflozin/Metformin (T)
fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
Drug: Empagliflozin/Metformin
medium dose of Empagliflozin oral administration

Experimental: 2 Empagliflozin/Metformin (T)
fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Drug: Empagliflozin/Metformin
medium dose of Empagliflozin oral administration

Experimental: 3 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fasted conditions
Drug: Empagliflozin
medium dose oral administration

Drug: Metformin
oral administration

Experimental: 4 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fed conditions
Drug: Empagliflozin
medium dose oral administration

Drug: Metformin
oral administration

Experimental: 5 Empagliflozin/Metformin (T)
fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Drug: Empagliflozin/Metformin
low dose of Empagliflozin

Experimental: 6 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fed conditions
Drug: Empagliflozin
low dose of Empagliflozin oral administration

Drug: Metformin
oral administration




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

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

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

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


Secondary 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, Empagliflozin [ Time Frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]
    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. 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 first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]
    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



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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): NCT01811953


Locations
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Germany
1276.8.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01811953     History of Changes
Other Study ID Numbers: 1276.8
2012-005156-42 ( EudraCT Number: EudraCT )
First Posted: March 15, 2013    Key Record Dates
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015
Last Verified: June 2015
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