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Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects

NCT02225626 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-05-12

No results posted yet for this study

Summary

Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male subjects as well as to investigate pharmacokinetics, safety and tolerability

Conditions

  • Healthy

Interventions

DRUG

BI 1060469

tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h

DRUG

BI 1060469

tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration

DRUG

Other: standard breakfast

tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration

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
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-11-30
Completion
2014-12-31

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 NCT02225626 on ClinicalTrials.gov