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Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

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ClinicalTrials.gov Identifier: NCT01581931
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : August 20, 2013
Last Update Posted : August 20, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE April 19, 2012
First Posted Date  ICMJE April 20, 2012
Results First Submitted Date  ICMJE June 14, 2013
Results First Posted Date  ICMJE August 20, 2013
Last Update Posted Date August 20, 2013
Study Start Date  ICMJE April 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
  • Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin [ Time Frame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours ]
    AUC0-tz represents the area under the concentration curve of metformin in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. Note, the geometric mean is actually an adjusted geometric mean.
  • Maximum Concentration (Cmax) of Metformin [ Time Frame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours ]
    Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • Number of participants with AUC0-tz (area under the plasma concentration-time curve over the time interval from 0 to the time tz of the last measurable concentration ) [ Time Frame: up to 72 hours ]
  • Number of participants with Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours ]
Change History Complete list of historical versions of study NCT01581931 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
  • Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin [ Time Frame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours ]
    AUC0-infty represents the area under the concentration curve of metformin in plasma from time 0 extrapolated to infinity. Note, the geometric mean is actually an adjusted geometric mean.
  • Time to Maximum Concentration (Tmax) of Metformin [ Time Frame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours ]
    Time from dosing to the maximum concentration of metformin in plasma.
  • Terminal Half-life t1/2 of Metformin [ Time Frame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours ]
    The terminal half-life of metformin in plasma is denoted by t1/2.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • Number of participants with AUC0-8 (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 ]
  • Number of participants with tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 72 hours ]
  • Number of participants with t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
Official Title  ICMJE Bioequivalence of Metformin Under Fed Conditions After Administration of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Male and Female Volunteers, (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial)
Brief Summary To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin
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: Linagliptin/metformin
    FDC
  • Drug: Metformin
    single tablet Metformin
  • Drug: Linagliptin
    single tablet Linagliptin
Study Arms  ICMJE
  • Experimental: Linagliptin/metformin
    fixed dose combination tablet (FDC)
    Intervention: Drug: Linagliptin/metformin
  • Experimental: Linagliptin and metformin
    single tablets
    Interventions:
    • Drug: Metformin
    • Drug: Linagliptin
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: April 19, 2012)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 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 55 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 NCT01581931
Other Study ID Numbers  ICMJE 1288.20
2011-005423-41 ( 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 June 2013

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