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

NCT ID: NCT02230995

Last Updated: 2017-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this trial is to demonstrate 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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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Inclusion Criteria

\- Healthy male and female subjects

Exclusion Criteria

\- Any relevant deviation from healthy condition.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Biberach an der Riss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2014-002016-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1276.15

Identifier Type: -

Identifier Source: org_study_id

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