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Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

NCT01653639 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-01-10

No results posted yet for this study

Summary

This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).

Conditions

Interventions

BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)

BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Bulgaria

Study Locations

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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 NCT01653639 on ClinicalTrials.gov