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Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

NCT01608087 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2019-11-08

Study results available
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Summary

This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.

Conditions

  • Healthy

Interventions

DRUG

BI 695502

BI 695502 single i.v. infusion

DRUG

bevacizumab

bevacizumab single i.v. infusion

DRUG

bevacizumab

bevacizumab single i.v. infusion

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-01
Primary Completion
2012-11-01
Completion
2012-11-01

Countries

  • New Zealand

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 NCT01608087 on ClinicalTrials.gov