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Study in Healthy Male Subjects to Investigate Whether Ketoconazole Affects Plasma Exposure of BI 113823

NCT ID: NCT01189175

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Brief Summary

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The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 113823

single oral dose per subject

Group Type EXPERIMENTAL

BI 113823

Intervention Type DRUG

single oral dose

BI 113823 + Ketokonazole

after wash-out 5 days ketokonazole with BI 113823 on day 3

Group Type EXPERIMENTAL

BI 113823 + Ketokonazole

Intervention Type DRUG

5 days ketokonazole with single oral dose of BI 113823 on day 3

Interventions

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BI 113823 + Ketokonazole

5 days ketokonazole with single oral dose of BI 113823 on day 3

Intervention Type DRUG

BI 113823

single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

healthy male subjects
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

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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1272.5.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-018542-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1272.5

Identifier Type: -

Identifier Source: org_study_id