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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Linagliptin/Pioglitazone; Drug: Linagliptin + Pioglitazone

• Registration Number: NCT01276327
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2011-05
• Status Verified: 2014-03
• Results First Submitted: 2014-03-12
• Results First Submitted QC: 2014-03-12
• Results First Posted: 2014-04-17
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 Linagliptin/Pioglitazone (Test)	Linagliptin/Pioglitazone	Fixed-Dose-Combination-Tablet, oral administration with 240 mL water
2 Linagliptin + Pioglitazone (Ref)	Linagliptin + Pioglitazone	Tablets, oral administration with 240 mL water for each treatment
3 Linagliptin/Pioglitazone (Test)	Linagliptin/Pioglitazone	Fixed-Dose-Combination-Tablet, oral administration with 240 mL water
4 Linagliptin + Pioglitazone (Ref)	Linagliptin + Pioglitazone	Tablets, oral administration with 240 mL water for each treatment

Primary Outcome Measures

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

Name	Time	Method
AUC0-tz 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)	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	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
AUC0-∞ of 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)	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	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
Tmax 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)	Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone

Trial Locations

Locations (1)

1264.14.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany