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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01383356
First received: June 27, 2011
Last updated: February 27, 2014
Last verified: February 2014

June 27, 2011
February 27, 2014
June 2011
December 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Maximum measured analyte concentration over the sampling period (Cmax) [ Time Frame: 35 Days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time of the maximum measured analyte concentration over the sampling period (Tmax) [ Time Frame: 35 Days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01383356 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.
Not Provided
Not Provided
Not Provided
 
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • Drug: Metformin Single Tablet
    Metformin medium doseTablet
  • Drug: Linagliptin/Metformin Combo
    Fixed dose combination
  • Drug: Linagliptin Single Tablet
    Linagliptin Single medium dose Tablet
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

1. Healthy male and female subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.

Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01383356
1288.19
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014

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