drugset / Trial / NCT00952822

Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection

NCT00952822 ↗

Phase 1 Completed 52 enrolled Baxalta now part of Shire
RandomizedCrossoverOpen-labelOther

Summary

The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water for injection (SWFI) and compare with those of rAHF-PFM reconstituted in 5 mL of SWFI.

Timeline

Start
2008-08-08
Primary completion
2009-10-23
Completion
2009-10-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) Protein / enzyme biologic — Other

Indications