Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: A: BI 10773 / metformin tablet; Drug: B: BI 10773 tablet and metformin tablet; Drug: C: BI 10773 / metformin tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211197

1276.5

2010-018589-22 (EudraCT Number)

Details and patient eligibility

About

The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males and females according to the following criteria
2. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

Exclusion criteria

1. Any finding of the medical examination (including Blood Pressure, Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

A

Experimental group

Description:

3 treatments will be investigated in randomized order

Treatment:

Drug: A: BI 10773 / metformin tablet

B

Experimental group

Description:

3 treatments will be investigated in randomized order

Treatment:

Drug: B: BI 10773 tablet and metformin tablet

C

Experimental group

Description:

3 treatments will be investigated in randomized order

Treatment:

Drug: C: BI 10773 / metformin tablet