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

Pfizer35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

voriconazoleDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults

Time frame: 14 days

Secondary Outcomes

The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults

Time frame: 14 days

Data from ClinicalTrials.gov

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