Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Linagliptin; Drug: Metformin; Drug: Linagliptin/Metformin FDC

• Registration Number: NCT02084056
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-11
• Study Start: 2014-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-06
• Results First Submitted: 2016-06-23
• Results First Submitted QC: 2016-06-23
• Last Update Submitted: 2016-06-23
• Results First Posted: 2016-08-04
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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
FDC first, fasted	Metformin	Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fasted
FDC first, fasted	Linagliptin/Metformin FDC	Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fasted
Single tablets first, fasted	Linagliptin/Metformin FDC	single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fasted
FDC first, fed	Linagliptin/Metformin FDC	Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fed
FDC first, fasted	Linagliptin	Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fasted
Single tablets first, fed	Linagliptin	single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fed
Single tablets first, fed	Metformin	single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fed
Single tablets first, fed	Linagliptin/Metformin FDC	single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fed
Single tablets first, fasted	Linagliptin	single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fasted
Single tablets first, fasted	Metformin	single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fasted
FDC first, fed	Linagliptin	Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fed
FDC first, fed	Metformin	Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fed

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration	AUC 0-72 (area under the concentration-time curve of Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Maximum Measured Concentration of Linagliptin in Plasma (Cmax)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration	Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration	AUC 0-tz (Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Cmax of Metformin in Plasma	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration	Cmax (maximum measured concentration of Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration	AUC0-inf (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.; The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
AUC0-inf of Metformin in Plasma	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration	AUC0-inf(area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity) for Metformin.; The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.

Trial Locations

Locations (1)

1288.11.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany