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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Empagliflozin/Metformin XR, FDC; Drug: Empagliflozin/Metformin XR FDC; Drug: 25 mg Empagliflozin/1000 mg Metformin XR, FDC; Drug: 1 tablet Empagliflozin/3 tablets Metformin XR; Drug: 1 tablet Empagliflozin/2 tablets Metformin XR

• Registration Number: NCT01975220
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-03
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-08
• Results First Submitted: 2017-01-18
• Results First Submitted QC: 2017-01-18
• Last Update Submitted: 2017-01-18
• Results First Posted: 2017-03-08
• Last Update Posted: 2017-03-08

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
High dose, fed	Empagliflozin/Metformin XR, FDC	1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions
Low dose, fasted	Empagliflozin/Metformin XR FDC	2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions
High dose, fasted	25 mg Empagliflozin/1000 mg Metformin XR, FDC	1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions
Low dose, fasted	1 tablet Empagliflozin/3 tablets Metformin XR	2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions
High dose, fasted	1 tablet Empagliflozin/2 tablets Metformin XR	1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions
High dose, fed	1 tablet Empagliflozin/2 tablets Metformin XR	1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 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 (AUC 0-tz); Empagliflozin
Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	Cmax (maximum measured concentration of the analyte in plasma); Metformin
AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin
Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin

Secondary Outcome Measures

Name	Time	Method
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin

Trial Locations

Locations (1)

1276.13.1 Boehringer Ingelheim Investigational Site; 🇺🇸 Austin, Texas, United States