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)
1 other identifier
interventional
72
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 4, 2014
CompletedFirst Posted
Study publicly available on registry
April 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
March 9, 2017
CompletedMarch 9, 2017
January 1, 2017
2 months
April 4, 2014
January 19, 2017
January 19, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
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
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
Study Arms (3)
High dose, fasted
EXPERIMENTAL1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted conditions
High dose, fed
EXPERIMENTAL1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions
Low dose, fasted
EXPERIMENTAL2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions
Interventions
Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets
Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets
Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets
Eligibility Criteria
You may qualify if:
- Healthy males or females
- Age 18-50 years (incl.)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
- Subjects must be able to understand and comply with study requirements
You may not qualify if:
- Any deviation from healthy condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Eli Lilly and Companycollaborator
Study Sites (1)
Boehringer Ingelheim Investigational Site
Austin, Texas, United States
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2014
First Posted
April 8, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
March 9, 2017
Results First Posted
March 9, 2017
Record last verified: 2017-01