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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: voriconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00855101

A1501092

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.