Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

Phase 1 Completed 18 enrolled Bayer

RandomizedCrossoverOpen-labelTreatment

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).

Timeline

Start: 2012-07
Primary completion: 2012-12
Completion: 2012-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADVATE	Protein / enzyme biologic	50 iu/kg	—

Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

Summary

Timeline

Drugs

Indications