Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: metformin (Glucophage®); Drug: empagliflozin and metformin; Drug: empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01844531

1276.6

2012-000082-20 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high fat, high caloric meal.

The assessment of safety and tolerability will be an additional objective of this trial.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects
2. Subjects must be able to understand and comply with study requirements
3. Age 18 to 50 years
4. Body mass index (BMI) 18.5 to 29.9 kg/m2

Exclusion criteria

1. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

FDC empagliflozin dose 1 and metformin

Experimental group

Description:

fix dose combination tablet after intake of a high fat, high caloric meal

Treatment:

Drug: empagliflozin and metformin

Drug: empagliflozin and metformin

empagliflozin dose 1 + metformin tablets

Active Comparator group

Description:

single tablets after intake of a high fat, high caloric meal

Treatment:

Drug: metformin (Glucophage®)

Drug: empagliflozin

Drug: metformin (Glucophage®)

Drug: empagliflozin

FDC empagliflozin dose 2 and metformin

Experimental group

Description:

fix dose combination tablet after intake of a high fat, high caloric meal

Treatment:

Drug: empagliflozin and metformin

Drug: empagliflozin and metformin

empagliflozin dose 2 + metformin tablets

Active Comparator group

Description:

single tablets after intake of a high fat, high caloric meal

Treatment:

Drug: metformin (Glucophage®)

Drug: empagliflozin

Drug: metformin (Glucophage®)

Drug: empagliflozin