CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Voriconazole low dose +1 moredrug
Likely dose
Voriconazole low dose 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01030653
NCT01030653Phase 4Completed

Pharmacokinetics of Voriconazole in Obese Subjects

Manjunath Prakash Pai·interventional·Posted Dec 11, 2009·Updated Feb 9, 2017

In Brief

A Phase 4 clinical trial evaluating Voriconazole low dose and Voriconazole high dose for Healthy. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Obese subjects may require a higher fixed oral maintenance dosing regimen of voriconazole compared to normal weight subjects to achieve comparable plasma exposures. The current study is designed to address this issue.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2009
Enrollment StartNov 1, 2009
Primary CompletionApr 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.6 years ago

Interventions

Voriconazole low dosedrug

Voriconazole 400 mg po x 2 doses (loading dose)then 200 mg po twice daily x 7 doses

Voriconazole high dosedrug

Voriconazole 400 mg po x 2 doses (loading dose)then 300 mg po twice daily x 7 doses