A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00855101

Purpose

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 I

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
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:

Drug Information available for: Voriconazole

U.S. FDA Resources

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
voriconazole: Experimental	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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855101

Locations

Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1501092
Study First Received:	March 2, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00855101 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pharmacokinetics and safety of voriconazole intravenous oral adults

Study placed in the following topic categories:

Anti-Infective Agents
Antifungal Agents
Voriconazole
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Voriconazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009