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Clinical Trial Details

Trial ID: L6290
Source ID: NCT01383356
Associated Drug: Metformin Single Tablet
Title: Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01383356/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Metformin Single Tablet|DRUG: Linagliptin/Metformin Combo|DRUG: Linagliptin Single Tablet
Outcome Measures: Primary: Maximum Plasma Concentration (Cmax), Maximum measured concentration of metformin in plasma, per period., 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., 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 | Secondary: 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., 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
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 58
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2011-06
Completion Date: 2011-12
Results First Posted: 2013-01-24
Last Update Posted: 2014-03-28
Locations: 1288.19.1 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada
URL: https://clinicaltrials.gov/show/NCT01383356