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NCT04035187 · ClinicalTrials.gov registry record · Phase 4
Itraconazole Oral Absorption
A Phase 4 study of Fungal Infection, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT04035187: Completed Phase 4 study of Fungal Infection, sponsored by University of Maryland, Baltimore.
NCT04035187 is a Phase 4 study of Fungal Infection that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 17 participants, below the 160-participant average among 6 other Fungal Infection trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04035187, a Phase 4 study of Fungal Infection, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
area under the curve from 0-72hr
Conditions Studied
Interventions
- DRUG fast itraconazole tablet
- DRUG medium itraconazole tablet
- DRUG slow itraconazole tablet
- DRUG oral itraconazole solution
Study Locations (1)
Maryland
- University of Maryland - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-02-10 |
| Est. Completion | 2022-05-21 |
| Phase | Phase 4 |
What the finished NCT04035187 record still lists
NCT04035187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 160-participant average among 6 other Fungal Infection trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Fungal Infection appearing as the primary indexed condition, and to 4 interventions - of which fast itraconazole tablet is the first listed.
NCT04035187 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04035187 about?
NCT04035187 is a clinical study titled "Itraconazole Oral Absorption". 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 diffe...
What is the current status of trial NCT04035187?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2020-02-10. Estimated completion is 2022-05-21.
What conditions does trial NCT04035187 study?
This clinical trial studies the following conditions: Fungal Infection.
What interventions are being tested in trial NCT04035187?
The interventions under investigation include: fast itraconazole tablet (DRUG), medium itraconazole tablet (DRUG), slow itraconazole tablet (DRUG), oral itraconazole solution (DRUG).
Who is sponsoring clinical trial NCT04035187?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04035187 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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