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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855101
• Other study ID #: A1501092
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2009
• Last updated: June 11, 2010
• Start date: April 2009
• Est. completion date: July 2009

Study information

• Verified date: June 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults		14 days	No
Secondary	The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults		14 days	Yes

External Links

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