Overview

This trial is active, not recruiting.

Condition healthy
Treatments high dose fdc empagliflozin/linagliptin/metformin xr, fed, 1 tab empagliflozin +1 tab linagliptin +2 tabs metformin xr, high dose fdc empagliflozin/linagliptin/metformin xr, fasted, low dose fdc empagliflozin/linagliptin/metformin xr, fed
Phase phase 1
Sponsor Boehringer Ingelheim
Collaborator Eli Lilly and Company
Start date July 2016
End date October 2016
Trial size 50 participants
Trial identifier NCT02821910, 1361.1, 2015-005082-23

Summary

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin & metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions
high dose fdc empagliflozin/linagliptin/metformin xr, fed
High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
1 tab empagliflozin +1 tab linagliptin +2 tabs metformin xr
1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
(Experimental)
1 fixed dose combination (FDC) tablet vs. 4 single tablets under fasted conditions
high dose fdc empagliflozin/linagliptin/metformin xr, fasted
High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
1 tab empagliflozin +1 tab linagliptin +2 tabs metformin xr
1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
(Experimental)
1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions
low dose fdc empagliflozin/linagliptin/metformin xr, fed
Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
1 tab empagliflozin +1 tab linagliptin +2 tabs metformin xr
1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

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

Eligibility Criteria

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

Inclusion criteria: - Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests - Age of 18 to 55 years (incl.) - BMI of 18.5 to 29.9 kg/m2 (incl.) - Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation - Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion: Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device Sexually abstinent A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) Surgically sterilised (including hysterectomy) Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone above 40 U/L and estradiol below 30 ng/L is confirmatory) Exclusion criteria: - Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) is 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, 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 - Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair) - Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders - Further exclusion criteria apply

Additional Information

Official title Relative Bioavailability of Two FDC Tablet Strengths of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin and Metformin Extended Release Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.