Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 10773 XX (Trial Formulation 2); Drug: BI 10773 (Final Formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01242176

1245.51

2010-022469-81 (EudraCT Number)

Details and patient eligibility

About

The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

Healthy male and female subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

BI 10773 Final Formulation

Experimental group

Description:

one single film-coated tablet in the morning

Treatment:

Drug: BI 10773 (Final Formulation)

BI 10773 XX Trial Formulation 2

Experimental group

Description:

one single dose tablet in the morning

Treatment:

Drug: BI 10773 XX (Trial Formulation 2)