Status:
COMPLETED
A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 profil...
Eligibility Criteria
Inclusion
- Healthy male and female subjects from 18 and 55 years old.
- Body weight between 40 kg (88 lbs) and 100 kg (220 lbs).
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00855101
Start Date
April 1 2009
End Date
July 1 2009
Last Update
June 14 2010
Active Locations (1)
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1
Pfizer Investigational Site
Brussels, Belgium, 1070