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Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers Including the Influence of Food on the Bioavailability of 10 mg BI 1356 BS

NCT02180503 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-07-08

No results posted yet for this study

Summary

Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a food effect for the 10 mg tablet dose group

Conditions

  • Healthy

Interventions

DRUG

BI 1356 BS PIB - low dose

DRUG

BI 1356 BS tablet - low dose

DRUG

BI 1356 BS PIB - high dose

DRUG

BI 1356 BS tablet - high dose

DRUG

BI 1356 BS tablet - high dose with food

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2005-10-31

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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 NCT02180503 on ClinicalTrials.gov