Overview

This trial is active, not recruiting.

Condition healthy
Treatments metformin, empagliflozin/metformin, empagliflozin
Phase phase 1
Sponsor Boehringer Ingelheim
Collaborator Eli Lilly and Company
Start date November 2014
End date December 2014
Trial size 30 participants
Trial identifier NCT02266472, 1276.28, 2014-002360-32

Summary

The purpose of this trial is to investigate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single dose empagliflozin/metformin
empagliflozin/metformin
Single dose empagliflozin/metformin given as fixed-dose combination tablet
(Active Comparator)
single doses empagliflozin and metformin
metformin
single dose of metformin given as tablets
empagliflozin
single dose of empagliflozin given as tablet

Primary Outcomes

Measure
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
time frame: up to 72 hours
Maximum measured concentration of empagliflozin in plasma (Cmax)
time frame: up to 72 hours
AUC0-tz of metformin in plasma
time frame: up to 72 hours
Cmax of metformin in plasma
time frame: up to 72 hours

Secondary Outcomes

Measure
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)
time frame: up to 72 hours
AUC0-infinity of metformin in plasma
time frame: up to 72 hours

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion criteria: - Healthy male and female subjects - age of 18 to 55 years - body mass index (BMI) of 18.5 to 29.9 kg/m2 - additional inclusion criteria may apply Exclusion criteria: - Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator - Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm - Any laboratory value outside the reference range that the investigator considers to be of clinical relevance - Any evidence of a concomitant disease judged as clinically relevant by the investigator - Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders - Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication - Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders - additional exclusion criteria may apply

Additional Information

Official title Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release (10 mg/1000 mg) Compared With the Free Combination of Empagliflozin and Metformin Extended Release Tablets in Healthy Subjects Following a High-fat, High-caloric Meal (an Open-label, Randomised, Single Dose, Crossover Trial)
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.