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Relative Bioavailability of 2 Oral Formulations of Nintedanib

NCT02572752 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-01-05

Study results available
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Summary

To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib compared to 2 soft gelatine capsules containing 100 mg nintedanib

Conditions

  • Healthy

Interventions

DRUG

Nintedanib

1 soft gelatine capsule, single dose, oral

DRUG

Nintedanib

Nintedanib, 2 soft gelatine capsules, single dose, oral

DRUG

Nintedanib

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
2015-08-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT02572752 on ClinicalTrials.gov