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Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I in Healthy Volunteers

NCT02182414 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-07-18

No results posted yet for this study

Summary

Study to investigate the relative bioavailability of 5 new 400 mg tablet formulations (trial formulation II prototypes) of BI 207127 compared to the current 200 mg BI 207127 tablet formulation (trial formulation I) in healthy male volunteers with the aim to identify the best formulation for further drug development (formulation finding part / trial part 1) and to investigate the effect of food on the relative bioavailability of the most promising one of these trial formulation II prototypes (food-effect part / trial part 2).

Conditions

  • Healthy

Interventions

DRUG

BI 207127 NA (TF-I)

200 mg tablet

DRUG

BI 207127 NA (TF-II)

400 mg tablet

DRUG

BI 207127 NA delayed release

400 mg tablet

DRUG

BI 207127 NA extended release (10% HPMC)

400 mg tablet

DRUG

BI 207127 NA extended release (15% PEO)

400 mg tablet

DRUG

BI 207127 NA extended release (20% HPMC)

400 mg tablet

Sponsors & Collaborators

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
2009-05-31
Primary Completion
2009-09-30

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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 NCT02182414 on ClinicalTrials.gov