NCT02266472 - Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Male and Female | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

30

Conditions

Healthy

Interventions

metforminDRUG

single dose of metformin given as tablets

empagliflozin/metforminDRUG

Single dose empagliflozin/metformin given as fixed-dose combination tablet

empagliflozinDRUG

single dose of empagliflozin given as tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Outcomes

Primary Outcomes

AUC0-tz of Empagliflozin in Plasma

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)