Drug Interaction Study of Digoxin and BI 10773

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Digoxin; Drug: Digoxin plus BI 10773

Study type: Interventional

Funder types: Industry

Identifiers

NCT01306175

2010-023170-40 (EudraCT Number)

1245.40

Details and patient eligibility

About

The objective of the study is to investigate the relative bioavailability of digoxin after concomitant multiple oral administration of BI 10773 and a single dose of digoxin in comparison to digoxin given alone to healthy male and female subjects.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Healthy male and female subjects

Exclusion criteria

-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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20 participants in 2 patient groups

Digoxin alone (Reference)

Experimental group

Description:

Tablet, oral administration with 240 mL water

Treatment:

Drug: Digoxin

Digoxin plus BI 10773 (Test)

Experimental group

Description:

Tablets, oral administration with 240 mL water

Treatment:

Drug: Digoxin plus BI 10773