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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: metformin; Drug: empagliflozin; Drug: empagliflozin/metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02230995

2014-002016-17 (EudraCT Number)

1276.15

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects

Exclusion criteria

• Any relevant deviation from healthy condition.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Fixed dose combination

Experimental group

Description:

Single dose empagliflozin/metformin

Treatment:

Drug: empagliflozin/metformin

Single tablets combination

Active Comparator group

Description:

single doses empagliflozin and metformin

Treatment:

Drug: empagliflozin

Drug: metformin