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

Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (25mg/1000mg and 12.5mg/750mg) of Empagliflozin/Metformin Extended Release Compared With the Free Combination of Empagliflozin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States
      • 1276.13.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Healthy males or females
2. Age 18-50 years (incl)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl)
4. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

Any deviation from healthy condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose, fasted; 1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions	Drug: 25 mg Empagliflozin/1000 mg Metformin XR, FDC; Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet; Drug: 1 tablet Empagliflozin/2 tablets Metformin XR; Active Comparator: 1x empagliflozin/2x metformin XR tablets
Experimental: High dose, fed; 1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions	Drug: 1 tablet Empagliflozin/2 tablets Metformin XR; Active Comparator: 1x empagliflozin/2x metformin XR tablets; Drug: Empagliflozin/Metformin XR, FDC; Experimental: high dose empagliflozin/metformin XR, FDC tablet
Experimental: Low dose, fasted; 2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions	Drug: Empagliflozin/Metformin XR FDC; Experimental: low dose empagliflozin/metformin XR, FDC tablet; Drug: 1 tablet Empagliflozin/3 tablets Metformin XR; Active Comparator: 1x empagliflozin/3x metformin XR tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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	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
Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin	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); Metformin	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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); 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); Metformin	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Eli Lilly and Company

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: October 29, 2013
• First Posted (Estimate): November 3, 2013

Study Record Updates

• Last Update Posted (Actual): March 8, 2017
• Last Update Submitted That Met QC Criteria: January 18, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Metformin; Empagliflozin
• Other Study ID Numbers: 1276.13