Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Empagliflozin + Metformin; Drug: Empagliflozin; Drug: Metformin

• Registration Number: NCT01672788
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2015-06-26
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-04
• Last Update Submitted: 2015-08-04
• Results First Posted: 2015-08-31
• Last Update Posted: 2015-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference 1	Metformin	empagliflozin tablets and metformin tablet
Test 2	Empagliflozin + Metformin	fixed dose combination tablet
Test 1	Empagliflozin + Metformin	fixed dose combination tablet
Reference 2	Metformin	empagliflozin tablet and metformin tablet
Reference 1	Empagliflozin	empagliflozin tablets and metformin tablet
Reference 2	Empagliflozin	empagliflozin tablet and metformin tablet

Primary Outcome Measures

Name	Time	Method
Empa: Area Under the Curve 0 to Infinity (AUC0-∞)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.; In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.; In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Empa: Maximum Measured Concentration (Cmax)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Maximum measured concentration of the analyte in plasma, per period.; In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Metformin: Maximum Measured Concentration (Cmax)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Maximum measured concentration of the analyte in plasma, per period.; In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Secondary Outcome Measures

Name	Time	Method
Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.; In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.; In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Trial Locations

Locations (1)

1276.7.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany