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Trial record 54 of 1385 for:    Area Under Curve AND tablet

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

Tracking Information
First Submitted Date  ICMJE August 22, 2012
First Posted Date  ICMJE August 27, 2012
Results First Submitted Date  ICMJE June 26, 2015
Results First Posted Date  ICMJE August 31, 2015
Last Update Posted Date August 31, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2012)
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72 hours after drug intake ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours after drug intake ]
Change History Complete list of historical versions of study NCT01672788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2012)
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) [ Time Frame: up to 72 hours after drug intake ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Empagliflozin
    empagliflozin tablets and metformin tablet
  • Drug: Empagliflozin + Metformin
    fixed dose combination tablet (low)
  • Drug: Metformin
    empagliflozin tablets and metformin tablet
  • Drug: Metformin
    empagliflozin tablet and metformin tablet
  • Drug: Empagliflozin
    empagliflozin tablet and metformin tablet
Study Arms  ICMJE
  • Experimental: Test 1
    fixed dose combination tablet
    Intervention: Drug: Empagliflozin + Metformin
  • Active Comparator: Reference 1
    empagliflozin tablets and metformin tablet
    Interventions:
    • Drug: Empagliflozin
    • Drug: Metformin
  • Experimental: Test 2
    fixed dose combination tablet
    Intervention: Drug: Empagliflozin + Metformin
  • Active Comparator: Reference 2
    empagliflozin tablet and metformin tablet
    Interventions:
    • Drug: Metformin
    • Drug: Empagliflozin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2012)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01672788
Other Study ID Numbers  ICMJE 1276.7
2012-002277-65 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP