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Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01581931
First received: April 19, 2012
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin


Condition Intervention Phase
Healthy
 Drug: Linagliptin/metformin
Drug: Metformin
Drug: Linagliptin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalence of Metformin Under Fed Conditions After Administration of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Male and Female Volunteers, (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Number of participants with AUC0-tz (area under the plasma concentration-time curve over the time interval from 0 to the time tz of the last measurable concentration ) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
  • Number of participants with Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
  • Number of participants with tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
  • Number of participants with t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: April 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Linagliptin/metformin
fixed dose combination tablet (FDC)
 Drug: Linagliptin/metformin
FDC
Experimental: Linagliptin and metformin
single tablets
 Drug: Metformin
single tablet Metformin
Drug: Linagliptin
single tablet Linagliptin

  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: NCT01581931

Locations
Germany
1288.20.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01581931     History of Changes
Other Study ID Numbers: 1288.20, 2011-005423-41
Study First Received: April 19, 2012
Last Updated: October 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
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 22, 2013