---
title: A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults
nct_id: NCT00855101
overall_status: COMPLETED
phase: PHASE1
sponsor: Pfizer
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00855101.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00855101"
ct_last_update_post_date: 2010-06-14
last_seen_at: "2026-05-12T06:28:53.913Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults

**Official Title:** 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

**NCT ID:** [NCT00855101](https://clinicaltrials.gov/study/NCT00855101)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 35
- **Lead Sponsor:** Pfizer
- **Conditions:** Healthy Volunteers
- **Start Date:** 2009-04
- **Completion Date:** 2009-07
- **CT.gov Last Update:** 2010-06-14

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **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.
```

## Arms

- **voriconazole** (EXPERIMENTAL)

## Interventions

- **voriconazole** (DRUG) — 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.

## 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)_

## Locations (1)

- Pfizer Investigational Site, Brussels, Belgium

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pfizer investigational site|brussels||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00855101.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00855101*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*