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

An Open-Label, Intravenous (6/4 Mg/Kg Q12h) To Oral Switch (200 Mg Q12h), Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Healthy Male And Female Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00855101

Enrollment

Registered

2009-03-04

Start date

2009-04-30

Completion date

2009-07-31

Last updated

2010-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics and safety of voriconazole intravenous oral adults

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.

Interventions

DRUGvoriconazole

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults	14 days

Secondary

Measure	Time frame
The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults	14 days

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026