Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

Phase 1

Completed

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

• Registration Number: NCT01581931
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-06
• Results First Submitted: 2013-06-14
• Results First Submitted QC: 2013-06-14
• Last Update Submitted: 2013-06-14
• Results First Posted: 2013-08-20
• Last Update Posted: 2013-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Linagliptin/metformin	Linagliptin/metformin	fixed dose combination tablet (FDC)
Linagliptin and metformin	Metformin	single tablets
Linagliptin and metformin	Linagliptin	single tablets

Primary Outcome Measures

Name	Time	Method
Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin	0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours	AUC0-tz represents the area under the concentration curve of metformin in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. Note, the geometric mean is actually an adjusted geometric mean.
Maximum Concentration (Cmax) of Metformin	0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours	Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.

Secondary Outcome Measures

Name	Time	Method
Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin	0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours	AUC0-infty represents the area under the concentration curve of metformin in plasma from time 0 extrapolated to infinity. Note, the geometric mean is actually an adjusted geometric mean.
Time to Maximum Concentration (Tmax) of Metformin	0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours	Time from dosing to the maximum concentration of metformin in plasma.
Terminal Half-life t1/2 of Metformin	0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours	The terminal half-life of metformin in plasma is denoted by t1/2.

Trial Locations

Locations (1)

1288.20.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany