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NCT02588326 · ClinicalTrials.gov registry record · Phase 1
Sensitivity of Pharmacokinetics to Differences in Particle Size Distribution of Suspension-based Nasal Sprays
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT02588326: Completed Phase 1 study, sponsored by University of Florida.
NCT02588326 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02588326, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
Currently FDA does not accept pharmacokinetic studies to show bioequivalence of locally-acting nasal suspension formulations. However, bioequivalence is defined as the absence of significant differences in pharmacokinetics of therapeutically equivalent drug products compared to the matching originally invented drug formulation. These there-called "generic drugs" are then interchangeable. Drug companies have to show that their generic version has the same active ingredient, the same label, is intended to be used for the same conditions or diseases and works at the same rate in the body. The aim of the study is to determine if pharmacokinetics is sensitive to differences in the particle size distribution of two different nasal suspension formulations of mometasone furoate during charcoal block. The result from this study will aid the FDA in finding methods to ensure that generic products are the same as the trade name drugs.
Interventions
- DRUG Mometasone furoate drug formulation (MFF) 1
- DRUG Mometasone furoate drug formulation (MFF) 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-09-21 |
| Est. Completion | 2021-04-16 |
| Phase | Phase 1 |
What the finished NCT02588326 record still lists
NCT02588326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Mometasone furoate drug formulation (MFF) 1 is the first listed.
NCT02588326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02588326 about?
NCT02588326 is a clinical study titled "Sensitivity of Pharmacokinetics to Differences in Particle Size Distribution of Suspension-based Nasal Sprays". Currently FDA does not accept pharmacokinetic studies to show bioequivalence of locally-acting nasal suspension formulations. However, bioequivalence is defined as the absence of significant differences in pharmacokinetics of therapeutically equivalent drug products compared to the matching origina...
What is the current status of trial NCT02588326?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2018-09-21. Estimated completion is 2021-04-16.
What interventions are being tested in trial NCT02588326?
The interventions under investigation include: Mometasone furoate drug formulation (MFF) 1 (DRUG), Mometasone furoate drug formulation (MFF) 2 (DRUG).
Who is sponsoring clinical trial NCT02588326?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02588326's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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