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Safety and Relative Bioavailability of BIBF 1120 Soft Gelatine Capsules Charge 1, BIBF 1120 Soft Gelatine Capsules Charge 2 and BIBF 1120 Drinking Solution in Healthy Male Volunteers

NCT02182193 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2014-07-18

No results posted yet for this study

Summary

To assess pharmacokinetics and the relative bioavailability of a single dose of BIBF 1120 soft gelatine capsule charge 1 vs. BIBF 1120 soft gelatine capsule charge 2 vs BIBF 1120 drinking solution in healthy male subjects respectively. To establish an in-vitro-in-vivo correlation (IVIVC) for oral soft gelatine capsules with 150 mg BIBF 1120 in healthy male volunteers (if feasible)

Conditions

  • Healthy

Interventions

DRUG

BIBF 1120 capsules charge 1

DRUG

BIBF 1120 capsules charge 2

DRUG

BIBF 1120 drinking solution

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2006-11-30

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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 NCT02182193 on ClinicalTrials.gov