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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 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 80 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02588326
The ClinicalTrials.gov registry entry for NCT02588326 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mometasone furoate drug formulation (MFF) 1 is the first listed.
NCT02588326 reports 0 study locations.
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.
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