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Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608

NCT ID: NCT01703858

Last Updated: 2017-01-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-01-31

Brief Summary

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The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects

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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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1 BI 113608

powder in the bottle for oral solution, oral administration with 240 mL water

Group Type ACTIVE_COMPARATOR

BI 113608 PIB

Intervention Type DRUG

powder for oral solution

2 BI 113608

conventional tablet formulation

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

conventional tablet formulation

3 BI 113608

conventional tablet formulation, fed

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

conventional tablet formulation

4 BI 113608

conventional tablet after pantoprazole administration

Group Type EXPERIMENTAL

pantoprazole 40 mg STADA

Intervention Type DRUG

film-coated tablet

BI 113608

Intervention Type DRUG

conventional tablet formulation

5 BI 113608

conventional tablet formulation, fasted, 0:30 min before fat breakfast

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

conventional tablet formulation

Interventions

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BI 113608 PIB

powder for oral solution

Intervention Type DRUG

BI 113608

conventional tablet formulation

Intervention Type DRUG

BI 113608

conventional tablet formulation

Intervention Type DRUG

BI 113608

conventional tablet formulation

Intervention Type DRUG

pantoprazole 40 mg STADA

film-coated tablet

Intervention Type DRUG

BI 113608

conventional tablet formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. healthy male subjects

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
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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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1314.3.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-002537-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1314.3

Identifier Type: -

Identifier Source: org_study_id

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