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

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ClinicalTrials.gov Identifier: NCT01276327
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : April 17, 2014
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Linagliptin + Pioglitazone Drug: Linagliptin/Pioglitazone Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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)
Study Start Date : January 2011
Actual Primary Completion Date : May 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours

  2. 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) ]
    Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.

  3. 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) ]
    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

  4. 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) ]
    Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.


Secondary Outcome Measures :
  1. 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) ]
    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

  2. 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) ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin

  3. 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) ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone

  4. 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) ]
    Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin

  5. 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) ]
    Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone


Eligibility Criteria
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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:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions

Contacts and Locations
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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): NCT01276327


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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01276327    
Other Study ID Numbers: 1264.14
2010-022649-29 ( EudraCT Number: EudraCT )
First Posted: January 13, 2011    Key Record Dates
Results First Posted: April 17, 2014
Last Update Posted: June 9, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Pioglitazone
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