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Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions

NCT ID: NCT01897597

Last Updated: 2013-09-06

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-09-30

Brief Summary

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The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.

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 144807 PfoS Treatment A

intermediate dose of BI 144807

Group Type EXPERIMENTAL

BI 144807 intermediate dose

Intervention Type DRUG

oral solution

BI 144807 PfoS Treatment C

high dose of BI 144807

Group Type EXPERIMENTAL

BI 144807 high dose

Intervention Type DRUG

oral solution

BI 144807 Tab Treatment B

intermediate dose of BI 144807

Group Type EXPERIMENTAL

BI 144807 intermediate dose

Intervention Type DRUG

tablet

BI 144807 Tab Treatment D

high dose of BI 144807

Group Type EXPERIMENTAL

BI 144807 high dose

Intervention Type DRUG

tablet

BI 144807 Tab Treatment E

intermediate dose of BI 144807, fasted

Group Type EXPERIMENTAL

BI 144807 intermediate dose

Intervention Type DRUG

tablet

BI 144807 Tab Treatment F

intermediate dose of BI 144807, fed

Group Type EXPERIMENTAL

BI 144807 intermediate dose

Intervention Type DRUG

tablet

BI 144807 Tab Treatment G

intermediate dose of BI 144807, fasted

Group Type EXPERIMENTAL

BI 144807 intermediate dose

Intervention Type DRUG

tablet

Interventions

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BI 144807 high dose

oral solution

Intervention Type DRUG

BI 144807 intermediate dose

tablet

Intervention Type DRUG

BI 144807 intermediate dose

tablet

Intervention Type DRUG

BI 144807 intermediate dose

tablet

Intervention Type DRUG

BI 144807 intermediate dose

tablet

Intervention Type DRUG

BI 144807 intermediate dose

oral solution

Intervention Type DRUG

BI 144807 high dose

tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Healthy male subjects

Exclusion Criteria

\- Any relevant deviation from healthy condition
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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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1313.9.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2013-000258-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1313.9

Identifier Type: -

Identifier Source: org_study_id