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

• 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 ]

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.

• 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

Inclusion criteria:

1. Healthy male and female subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.