Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Empagliflozin; Drug: Metformin; Drug: Empagliflozin/Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01811953

2012-005156-42 (EudraCT Number)

1276.8

Details and patient eligibility

About

Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

Enrollment: 48 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects

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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48 participants in 6 patient groups

1 Empagliflozin/Metformin (T)

Experimental group

Description:

fixed-dose-combination tablet, oral with 240 ml water under fasted conditions

Treatment:

Drug: Empagliflozin/Metformin

Drug: Empagliflozin/Metformin

Drug: Empagliflozin/Metformin

2 Empagliflozin/Metformin (T)

Experimental group

Description:

fixed-dose-combination tablet, oral with 240 ml water under fed conditions

Treatment:

Drug: Empagliflozin/Metformin

Drug: Empagliflozin/Metformin

Drug: Empagliflozin/Metformin

3 Empagliflozin + Metformin (R)

Experimental group

Description:

tablets, oral with 240 ml water under fasted conditions

Treatment:

Drug: Empagliflozin

Drug: Metformin

Drug: Metformin

Drug: Empagliflozin

Drug: Empagliflozin

Drug: Metformin

4 Empagliflozin + Metformin (R)

Experimental group

Description:

tablets, oral with 240 ml water under fed conditions

Treatment:

Drug: Empagliflozin

Drug: Metformin

Drug: Metformin

Drug: Empagliflozin

Drug: Empagliflozin

Drug: Metformin

5 Empagliflozin/Metformin (T)

Experimental group

Description:

fixed-dose-combination tablet, oral with 240 ml water under fed conditions

Treatment:

Drug: Empagliflozin/Metformin

Drug: Empagliflozin/Metformin

Drug: Empagliflozin/Metformin

6 Empagliflozin + Metformin (R)

Experimental group

Description:

tablets, oral with 240 ml water under fed conditions

Treatment:

Drug: Empagliflozin

Drug: Metformin

Drug: Metformin

Drug: Empagliflozin

Drug: Empagliflozin

Drug: Metformin