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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

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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

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Metformin Single Tablet Drug: Linagliptin/Metformin Combo Drug: Linagliptin Single Tablet Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : June 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Linagliptin/Metformin medium dosecombo
patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily
Drug: Linagliptin/Metformin Combo
Fixed dose combination
Active Comparator: Linagliptin plus Metformin medium dose
patient to receive two individual tablets: Linagliptin and Metformin (medium dose)
Drug: Metformin Single Tablet
Metformin medium doseTablet
Drug: Linagliptin Single Tablet
Linagliptin Single medium dose Tablet



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male and female subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383356


Locations
Canada, Ontario
1288.19.1 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01383356     History of Changes
Other Study ID Numbers: 1288.19
First Posted: June 28, 2011    Key Record Dates
Results First Posted: January 24, 2013
Last Update Posted: March 28, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action