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

NCT ID: NCT02266472

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2014-12-31

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fixed dose combination

Single dose empagliflozin/metformin

Group Type: EXPERIMENTAL

empagliflozin/metformin

Intervention Type: DRUG

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

Single tablets combination

single doses empagliflozin and metformin

Group Type: ACTIVE_COMPARATOR

metformin

Intervention Type: DRUG

single dose of metformin given as tablets

empagliflozin

Intervention Type: DRUG

single dose of empagliflozin given as tablet

Interventions

metformin

single dose of metformin given as tablets

Intervention Type: DRUG

empagliflozin/metformin

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

Intervention Type: DRUG

empagliflozin

single dose of empagliflozin given as tablet

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Countries

Germany

Other Identifiers

2014-002360-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1276.28

Identifier Type: -

Identifier Source: org_study_id