Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 10 mg Empagliflozin/1000 mg Metformin XR; Drug: 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR; Drug: 1 tablet Empagliflozin/2 tablets Metformin XR; Drug: 2 tablets 5 mg Empagliflozin/750 Metformin XR

• Registration Number: NCT02106923
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2017-01
• Results First Submitted: 2017-01-19
• Results First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Results First Posted: 2017-03-09
• Last Update Posted: 2017-03-09

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, fasted	10 mg Empagliflozin/1000 mg Metformin XR	1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted 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
High dose, fed	10 mg Empagliflozin/1000 mg Metformin XR	1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions
Low dose, fasted	1 tablet 10 mg Empagliflozin/3 tablets Metformin XR	2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions
Low dose, fasted	2 tablets 5 mg Empagliflozin/750 Metformin XR	2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions

Primary Outcome Measures

Name	Time	Method
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 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 empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 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 metformin in plasma over the time interval from 0 to the last quantifiable data point
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	Maximum measured concentration of empagliflozin in plasma (Cmax).
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	Maximum measured concentration of metformin in plasma

Secondary Outcome Measures

Name	Time	Method
AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 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 empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).
AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 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 metformin in plasma over the time interval from 0 extrapolated to infinity

Trial Locations

Locations (1)

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