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Relative Bioavailability of of Olodaterol and Ketoconazole

NCT ID: NCT01153711

Last Updated: 2014-04-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 1744 10 mcg

solution for oral inhalation

Group Type EXPERIMENTAL

BI 1744

Intervention Type DRUG

10 mcg solution for oral inhalation

Ketoconazole

Intervention Type DRUG

400 mg tablet

Ketoconazole 400 mg

tablet

Group Type EXPERIMENTAL

BI 1744

Intervention Type DRUG

10 mcg solution for oral inhalation

Ketoconazole

Intervention Type DRUG

400 mg tablet

Interventions

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BI 1744

10 mcg solution for oral inhalation

Intervention Type DRUG

BI 1744

10 mcg solution for oral inhalation

Intervention Type DRUG

Ketoconazole

400 mg tablet

Intervention Type DRUG

Ketoconazole

400 mg tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion criteria Healthy male and female volunteers

Exclusion criteria
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1222.47.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-018527-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1222.47

Identifier Type: -

Identifier Source: org_study_id