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Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food

NCT ID: NCT01286571

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 135585 (T)

single dose per subject as tablet formulation after high fat, high caloric meal

Group Type EXPERIMENTAL

BI 135585

Intervention Type DRUG

one oral single dose per subject

BI 135585 (R)

single dose per subject as tablet formulation after an overnight fast

Group Type EXPERIMENTAL

BI 135585

Intervention Type DRUG

one oral single dose per subject

Interventions

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BI 135585

one oral single dose per subject

Intervention Type DRUG

BI 135585

one oral single dose per subject

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- healthy male subjects

Exclusion Criteria

\- Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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1283.3.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-022697-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1283.3

Identifier Type: -

Identifier Source: org_study_id