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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 2, 2009
Last updated: June 11, 2010
Last verified: June 2010
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.

Condition Intervention Phase
Healthy Volunteers
Drug: voriconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: April 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: voriconazole Drug: voriconazole
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.
Other Name: Vfend


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00855101

Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00855101     History of Changes
Other Study ID Numbers: A1501092 
Study First Received: March 2, 2009
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pharmacokinetics and safety of voriconazole intravenous oral adults

Additional relevant MeSH terms:
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016