A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults
This study is to assess the plasma concentration-time profile of voriconazole in adults receiving 7-day intravenous treatment and 6.5-day oral treatment. This study is also to assess the safety profile of voriconazole during the treatment period.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Open-Label, Intravenous (6/4 Mg/Kg Q12h) To Oral Switch (200 Mg Q12h), Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Healthy Male And Female Adults|
- The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
6 mg/kg IV q12h on Day 1, and 4 mg/kg IV q12h on Days 2-7, then switch to 200 mg oral tablet q12h on Days 8-14.
Other Name: Vfend