CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 17 enrolled
Drug / intervention
fast itraconazole tablet +3 moredrug
Likely dose
fast itraconazole tablet 100mgfrom 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/NCT04035187
NCT04035187Phase 4Completed
CompareCT.gov

Prediction of Itraconazole Oral Absorption From In Vitro Dissolution

University of Maryland, Baltimore·interventional·Posted Jul 29, 2019·Updated Oct 5, 2023

In Brief

A Phase 4 clinical trial evaluating fast itraconazole tablet, medium itraconazole tablet, and 2 other interventions for Fungal Infection. Completed, enrolled 17 participants across 1 site.

Detailed Summary

For tablets to be absorbed, the drug must dissolve after being swallowed. Drugs with low solubility sometimes require the inert ingredients in tablets to help the drug dissolve after being swallowed. This study uses itraconazole as an example drug with low solubility. Itraconazole tablets with different inert ingredients and manufacturing will be administered to healthy volunteers to see if the different inert ingredients and manufacturing impact drug absorption.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFungal Infection
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJul 29, 2019
Enrollment StartFeb 10, 2020
Primary CompletionMay 21, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.9 years ago

Interventions

fast itraconazole tabletdrug

100mg dose

medium itraconazole tabletdrug

100mg dose

slow itraconazole tabletdrug

100mg dose

oral itraconazole solutiondrug

100mg dose