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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

NCT01897597 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2013-09-06

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

BI 144807 high dose

oral solution

DRUG

BI 144807 intermediate dose

tablet

DRUG

BI 144807 intermediate dose

tablet

DRUG

BI 144807 intermediate dose

tablet

DRUG

BI 144807 intermediate dose

tablet

DRUG

BI 144807 intermediate dose

oral solution

DRUG

BI 144807 high dose

tablet

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01897597 on ClinicalTrials.gov