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BIBW 2992 Administered as Tablet (Final Formulation) Compared to BIBW 2992 Drinking Solution and BIBW 2992 Tablet (Trial Formulation II) in Healthy Male Volunteers

NCT02171715 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2014-06-24

No results posted yet for this study

Summary

The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics of 20 mg BIBW 2992 administered as film-coated immediate release tablet (final formulation, i.e. phase III/to-be-marketed formulation) to healthy subjects in comparison with the drinking solution and in comparison with the trial formulation II tablet, which was administered in phase II clinical trials and also partly in phase I trials.

Conditions

  • Healthy

Interventions

DRUG

BIBW 2992 MA2

film-coated immediate release tablet - final formulation

DRUG

BIBW 2992 MA2

film-coated immediate release tablet - trial formulation II

DRUG

BIBW 2992 MA2

powder for oral solution

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-04-30

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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 NCT02171715 on ClinicalTrials.gov