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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
58
Metformin medium doseTablet
Fixed dose combination
Linagliptin Single medium dose Tablet
1288.19.1 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Maximum Plasma Concentration (Cmax)
Maximum measured concentration of metformin in plasma, per period.
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
Area Under the Curve 0 to Last Measurable Value (AUC0-t)
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.
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
Area Under the Curve 0 to Inf (AUC0-inf)
AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.