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:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01383356
First received: June 27, 2011
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Metformin Single Tablet Drug: Linagliptin/Metformin Combo Drug: Linagliptin Single Tablet |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 58 |
| Study Start Date: | June 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
1. Healthy male and female subjects.
Exclusion criteria:
1. Any relevant deviation from healthy conditions.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383356
Locations
| Canada, Ontario | |
| 1288.19.1 Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01383356 History of Changes |
| Other Study ID Numbers: | 1288.19 |
| Study First Received: | June 27, 2011 |
| Results First Received: | December 18, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases BI 1356 Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013