Relative Bioavailability of of Olodaterol and Ketoconazole

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy; Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Ketoconazole; Drug: BI 1744

Study type: Interventional

Funder types: Industry

Identifiers

NCT01153711

2010-018527-25 (EudraCT Number)

1222.47

Details and patient eligibility

About

This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol

Enrollment: 32 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria Healthy male and female volunteers

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

BI 1744 10 mcg

Experimental group

Description:

solution for oral inhalation

Treatment:

Drug: BI 1744

Drug: BI 1744

Drug: Ketoconazole

Drug: Ketoconazole

Ketoconazole 400 mg

Experimental group

Description:

tablet

Treatment:

Drug: BI 1744

Drug: BI 1744

Drug: Ketoconazole

Drug: Ketoconazole