A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children
This study has been completed.
Information provided by:
First received: September 12, 2005
Last updated: May 9, 2011
Last verified: May 2011
This is a study to investigate the pharmacokinetics, safety and tolerability of several doses of voriconazole, intravenous and oral suspension formulations, in children
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Intravenous to Oral Switch, Multiple Dose Multi-Centre Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Hospitalized Children Aged 2 to 12 Years Who Require Treatment for the Prevention of Systemic Fungal Infections.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The primary objective was to investigate the pharmacokinetics of voriconazole following intravenous (iv) to oral administration in immunocompromised children aged 2 to <12years.
Secondary Outcome Measures:
- The secondary objective was to evaluate the safety and tolerability of multiple dose administration of voriconazole in immunocompromised children requiring treatment for the prevention of systemic fungal infection.
|Study Start Date:||June 2003|
|Study Completion Date:||August 2005|
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