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

This study has been completed.
Information provided by:
Pfizer 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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00855101

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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00855101     History of Changes
Other Study ID Numbers: A1501092
Study First Received: March 2, 2009
Last Updated: June 11, 2010

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

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors processed this record on August 17, 2017