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BAY94-9027 PK Study Comparing to Another Long Acting Product

NCT03364998 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-09-09

No results posted yet for this study

Summary

The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.

Conditions

Interventions

DRUG

Damoctocog (Jivi, BAY94-9027)

60 international units (IU)/kg, given as a 10 minute injection, 1 dose

DRUG

Elocta

60 IU/kg, given as a 10 minute injection, 1 dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2018-01-25
Completion
2018-09-28
FDA Drug
Yes

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Diseases
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 NCT03364998 on ClinicalTrials.gov