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

Boehringer Ingelheim31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

BI 144807 high doseDRUG

BI 144807 intermediate doseDRUG

oral solution

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: \- Healthy male subjects Exclusion criteria: \- Any relevant deviation from healthy condition

Locations (1)

1313.9.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Outcomes

Primary Outcomes

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

Time frame: 48 hours

Maximum measured concentration of the analyte in plasma (Cmax)

Time frame: 48 hours

Secondary Outcomes

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)

Time frame: 48 hours

Data from ClinicalTrials.gov

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