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: June 3, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Pioglitazone
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 11, 2014