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Completed

NCT Number: NCT00855101

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Vfend

Primary outcomes

  1. The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults

    Time frame: 14 days

Secondary outcomes

  1. The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 4, 2009
Registry last updated
Jun 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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