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Relative Bioavailability of Olodaterol and Fluconazole

NCT ID: NCT01153724

Last Updated: 2014-06-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 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 CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol

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Detailed Description

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Conditions

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Healthy Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Olodaterol

Group Type EXPERIMENTAL

BI 1744

Intervention Type DRUG

10 mcg solution for oral inhalation

Olodaterol + Fluconazole

Group Type EXPERIMENTAL

BI 1744

Intervention Type DRUG

10 mcg solution for oral inhalation

Fluconazole

Intervention Type DRUG

400 mg capsule

Interventions

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BI 1744

10 mcg solution for oral inhalation

Intervention Type DRUG

Fluconazole

400 mg capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Healthy male and female volunteers
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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1222.48.1 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-018528-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1222.48

Identifier Type: -

Identifier Source: org_study_id

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