Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01276327
First received: January 12, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.


Condition Intervention Phase
Healthy
Drug: Linagliptin + Pioglitazone
Drug: Linagliptin/Pioglitazone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin 5 mg / Pioglitazone 30 mg Compared With Its Mono-components in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Replicate Design Study With Two Treatments in Four Crossover Periods)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUC0-72 of Linagliptin [ Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours

  • Cmax of Linagliptin [ Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) ] [ Designated as safety issue: No ]
    Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.

  • AUC0-tz of Pioglitazone [ Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point

  • Cmax of Pioglitazone [ Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) ] [ Designated as safety issue: No ]
    Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.


Secondary Outcome Measures:
  • AUC0-tz for Linagliptin [ Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for Linagliptin

  • AUC0-∞ of Linagliptin [ Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin

  • AUC0-∞ of Pioglitazone [ Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone

  • Tmax for Linagliptin [ Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) ] [ Designated as safety issue: No ]
    Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin

  • Tmax for Pioglitazone [ Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) ] [ Designated as safety issue: No ]
    Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone


Enrollment: 64
Study Start Date: January 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Linagliptin/Pioglitazone (Test)
Fixed-Dose-Combination-Tablet, oral administration with 240 mL water
Drug: Linagliptin/Pioglitazone
Medium dose oral administration
Experimental: 2 Linagliptin + Pioglitazone (Ref)
Tablets, oral administration with 240 mL water for each treatment
Drug: Linagliptin + Pioglitazone
Medium doses, oral administration
Experimental: 3 Linagliptin/Pioglitazone (Test)
Fixed-Dose-Combination-Tablet, oral administration with 240 mL water
Drug: Linagliptin/Pioglitazone
Medium dose oral administration
Experimental: 4 Linagliptin + Pioglitazone (Ref)
Tablets, oral administration with 240 mL water for each treatment
Drug: Linagliptin + Pioglitazone
Medium doses, oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276327

Locations
Germany
1264.14.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01276327     History of Changes
Other Study ID Numbers: 1264.14, 2010-022649-29
Study First Received: January 12, 2011
Results First Received: March 12, 2014
Last Updated: March 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Pioglitazone
BI 1356
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 April 17, 2014