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Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers

NCT01679613 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2014-11-27

Study results available
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Summary

The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state

Conditions

  • Healthy

Interventions

DRUG

Nintedanib

low or medium dose depending on pilot part

DRUG

Nintedanib

low dose oral administration

DRUG

Ketoconazole

oral administration

DRUG

Nintedanib

low dose oral administration

DRUG

Nintedanib

low or medium dose depending on pilot part

DRUG

Ketoconazole

oral administration

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
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-11-30
Completion
2012-11-30

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 NCT01679613 on ClinicalTrials.gov