Completed

An Open Label, Randomised, Single Dose, 3-way Cross Over Study to Investigate Relative Bioavailability and Food Effect on Different Formulations of BI 113608 in Healthy Male Subjects, Followed by Fixed Sequence Periods Investigating Influence of Pantoprazole Coadministration and Food Effect on Pharmacokinetics of Different Formulations of BI 113608

What is being tested

BI 113608 PIB

+ BI 113608

Drug

Who is being recruted

From 18 to 50 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: September 2012

See protocol details

Summary

Principal SponsorBoehringer Ingelheim

Last updated: January 20, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01703858

Principal SponsorBoehringer Ingelheim

Last updated: January 20, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate

1. healthy male subjects

1 exclusion criteria prevent from participating

1. Any relevant deviation from healthy conditions

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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

Group II

Experimental

conventional tablet formulation

Group III

Experimental

conventional tablet formulation, fed

Group IV

Experimental

conventional tablet after pantoprazole administration

Group 5

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

1314.3.1 Boehringer Ingelheim Investigational Site

Ingelheim, GermanyOpen 1314.3.1 Boehringer Ingelheim Investigational Site in Google Maps

CompletedOne Study Center