A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Voriconazole

Criteria

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.