Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Empagliflozin + Metformin; Drug: Metformin; Drug: Empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01672788

1276.7

2012-002277-65 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.

Enrollment: 36 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)

---

36 participants in 4 patient groups

Test 1

Experimental group

Description:

fixed dose combination tablet

Treatment:

Drug: Empagliflozin + Metformin

Drug: Empagliflozin + Metformin

Reference 1

Active Comparator group

Description:

empagliflozin tablets and metformin tablet

Treatment:

Drug: Metformin

Drug: Metformin

Drug: Empagliflozin

Drug: Empagliflozin

Test 2

Experimental group

Description:

fixed dose combination tablet

Treatment:

Drug: Empagliflozin + Metformin

Drug: Empagliflozin + Metformin

Reference 2

Active Comparator group

Description:

empagliflozin tablet and metformin tablet

Treatment:

Drug: Metformin

Drug: Metformin

Drug: Empagliflozin

Drug: Empagliflozin