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

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)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Linagliptin/Pioglitazone; Drug: Linagliptin + Pioglitazone

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany
    • 1264.14.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-72 of Linagliptin	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours	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)
Cmax of Linagliptin	Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.	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)
AUC0-tz of Pioglitazone	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	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)
Cmax of Pioglitazone	Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-tz for Linagliptin	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	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)
AUC0-∞ of Linagliptin	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin	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)
AUC0-∞ of Pioglitazone	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone	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)
Tmax for Linagliptin	Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin	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)
Tmax for Pioglitazone	Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone	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)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 12, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Estimate): June 9, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Pioglitazone; Linagliptin
• Other Study ID Numbers: 1264.14; 2010-022649-29 (EudraCT Number: EudraCT)