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Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01383356
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : January 24, 2013
Last Update Posted : March 28, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE June 27, 2011
First Posted Date  ICMJE June 28, 2011
Results First Submitted Date  ICMJE December 18, 2012
Results First Posted Date  ICMJE January 24, 2013
Last Update Posted Date March 28, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • Maximum Plasma Concentration (Cmax) [ Time Frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period ]
    Maximum measured concentration of metformin in plasma, per period.
  • Area Under the Curve 0 to Last Measurable Value (AUC0-t) [ Time Frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period ]
    AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
  • Pharmacokinetic parameters which will be obtained for metformin are the area under the analyte concentration versus time curve (AUCt) from time zero to the time of the last measurable analyte concentration will be measured [ Time Frame: 35 Days ]
  • Pharmacokinetic parameters which will be obtained for Metformin are the area under the analyte concentration versus time curve (AUCinf) from time zero to infinity will be measured. [ Time Frame: 35 Days ]
  • Maximum measured analyte concentration over the sampling period (Cmax) [ Time Frame: 35 Days ]
  • Time of the maximum measured analyte concentration over the sampling period (Tmax) [ Time Frame: 35 Days ]
  • The ratio of area under the analyte concentration versus time (AUCt) and area under the analyte concentration from time zero to infinity (AUCinf) will be measured. [ Time Frame: 35 DAYS ]
Change History Complete list of historical versions of study NCT01383356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Area Under the Curve 0 to Inf (AUC0-inf) [ Time Frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period ]
AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
Official Title  ICMJE A Single Dose Comparative Bioavailability Study of Linagliptin/Metformin hydrochloride2.5mg/500mg Combination Tablets Versus Linagliptin 2.5mg Tablets Administered With Glucophage 500mg Tablets Under Fasting Conditions
Brief Summary The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.
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: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Metformin Single Tablet
    Metformin medium doseTablet
  • Drug: Linagliptin/Metformin Combo
    Fixed dose combination
  • Drug: Linagliptin Single Tablet
    Linagliptin Single medium dose Tablet
Study Arms  ICMJE
  • Experimental: Linagliptin/Metformin medium dosecombo
    patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily
    Intervention: Drug: Linagliptin/Metformin Combo
  • Active Comparator: Linagliptin plus Metformin medium dose
    patient to receive two individual tablets: Linagliptin and Metformin (medium dose)
    Interventions:
    • Drug: Metformin Single Tablet
    • Drug: Linagliptin Single Tablet
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: March 7, 2012)
58
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2011)
18
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01383356
Other Study ID Numbers  ICMJE 1288.19
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 February 2014

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