Viewing Study NCT04035187



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Last Modification Date: 2024-10-26 @ 1:15 PM
Study NCT ID: NCT04035187
Status: COMPLETED
Last Update Posted: 2023-10-05
First Post: 2019-07-24

Brief Title: Itraconazole Oral Absorption
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: Prediction of Itraconazole Oral Absorption From In Vitro Dissolution
Status: COMPLETED
Status Verified Date: 2023-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None