NCT04035187

Itraconazole Oral Absorption

Prediction of Itraconazole Oral Absorption From In Vitro Dissolution

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fungal Infection

Interventions

Type	Name	Description
DRUG	fast itraconazole tablet	100mg dose
DRUG	medium itraconazole tablet	100mg dose
DRUG	slow itraconazole tablet	100mg dose
DRUG	oral itraconazole solution	100mg dose

Timeline

• Start date: 2020-02-10
• Primary completion: 2022-05-21
• Completion: 2022-05-21
• First posted: 2019-07-29
• Last updated: 2023-10-05
• Results posted: 2023-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study