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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01276327
First received: January 12, 2011
Last updated: October 19, 2011
Last verified: October 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Linagliptin: AUC0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Linagliptin: Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Pioglitazone: AUC0-tz (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) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Pioglitazone: Cmax [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics for linagliptin: AUC0-tz [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics for linagliptin and pioglitazone: AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics for linagliptin and pioglitazone: tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: 5 months ] [ Designated as safety issue: No ]

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 Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01276327     History of Changes
Other Study ID Numbers: 1264.14, 2010-022649-29
Study First Received: January 12, 2011
Last Updated: October 19, 2011
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 June 17, 2013