A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults
- Registration Number
- NCT00855101
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Healthy male and female subjects from 18 and 55 years old.
- Body weight between 40 kg (88 lbs) and 100 kg (220 lbs).
Exclusion Criteria
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, ocular, neurologic, or allergic disease.
- Subjects with any condition possibly affecting drug absorption, eg, gastrectomy.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description voriconazole voriconazole -
- Primary Outcome Measures
Name Time Method The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults 14 days
- Secondary Outcome Measures
Name Time Method The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults 14 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Bruxelles, Belgium