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

Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (10 mg/1000 mg and 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 combinations (FDC) tablets containing empagliflozin & metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly

Study Overview

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

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

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• 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
• Masking: NONE

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: 1 tablet Empagliflozin/2 tablets Metformin XR; Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets; Drug: 10 mg Empagliflozin/1000 mg Metformin XR; Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
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: 1 x Empagliflozin/2x Metformin XR tablets; Drug: 10 mg Empagliflozin/1000 mg Metformin XR; Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
EXPERIMENTAL: Low dose, fasted; 2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions	Drug: 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR; Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets; Drug: 2 tablets 5 mg Empagliflozin/750 Metformin XR; Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).	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
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	Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point	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
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin	Maximum measured concentration of empagliflozin in plasma (Cmax).	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
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin	Maximum measured concentration of metformin in plasma	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin	Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).	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
AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin	Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity	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

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: April 1, 2014
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (ESTIMATE): April 8, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

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: 1276.14