Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 2x500 mg Metformin (Glumetza); Drug: 2 x 2.5 mg Linagliptin/750 mg Metformin FDC; Drug: 5 mg Linagliptin/1000 mg Metformin FDC; Drug: 3x500 mg Metformin (Glumetza); Drug: 5 mg Linagliptin/1000mg Metformin FDC; Drug: 5 mg Linagliptin (Tradjenta); Drug: 2 x 500 mg Metformin (Glumetza)

• Registration Number: NCT01845077
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin \& metformin and the single tablets of linagliptin and metformin when administered singularly.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-30
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-07
• Results First Submitted: 2014-07-29
• Results First Submitted QC: 2014-07-29
• Last Update Submitted: 2014-07-29
• Results First Posted: 2014-08-19
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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
5 mg Linagliptin/1500 mg Metformin	5 mg Linagliptin (Tradjenta)	4 single tablets under fasted conditions
5 mg Linagliptin/1000 mg Metformin	5 mg Linagliptin (Tradjenta)	3 single tablets under fasted conditions
5 mg Linagliptin/1000 mg Metformin, fed	5 mg Linagliptin (Tradjenta)	3 single tablets under fed conditions
5 mg Linagliptin/1000 mg Metformin, fed	2x500 mg Metformin (Glumetza)	3 single tablets under fed conditions
5 mg Linagliptin/1500 mg Metformin FDC	2 x 2.5 mg Linagliptin/750 mg Metformin FDC	2 FDC tablets under fasted conditions
5 mg Linagliptin/1000 mg Metformin	2 x 500 mg Metformin (Glumetza)	3 single tablets under fasted conditions
5mg Linagliptin/1000mg Metformin, FDCfed	5 mg Linagliptin/1000 mg Metformin FDC	1 FDC tablet under fed conditions
5 mg Linagliptin/1500 mg Metformin	3x500 mg Metformin (Glumetza)	4 single tablets under fasted conditions
5 mg Linagliptin/1000 mg Metformin FDC	5 mg Linagliptin/1000mg Metformin FDC	1 fixed dose combination(FDC) tablet under fasted conditions

Primary Outcome Measures

Name	Time	Method
Cmax of Metformin	1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period	Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
AUC0-72 of Linagliptin	1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period	Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Cmax of Linagliptin	1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period	Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
AUC0-tz of Metformin	1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period	Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.

Secondary Outcome Measures

Name	Time	Method
AUC0-infinity of Linagliptin	1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period	Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
AUC0-infinity of Metformin	1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period	Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.

Trial Locations

Locations (1)

1288.8.1 Boehringer Ingelheim Investigational Site; 🇺🇸 Austin, Texas, United States