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NCT02588326
Sensitivity of Pharmacokinetics to Differences in Particle Size Distribution of Suspension-based Nasal Sprays
Phase 1 trial testing Mometasone furoate drug formulation (MFF) 1 in Hypersensitivity in 80 participants. Completed in 16 April 2021.
8 July 2020
Quick facts
| Lead sponsor | University of Florida |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | other |
| Enrollment | 80 |
| Start date | 21 September 2018 |
| Primary completion | 8 July 2020 |
| Estimated completion | 16 April 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Mometasone furoate drug formulation (MFF) 1 — full drug profile →
- Mometasone furoate drug formulation (MFF) 2 — full drug profile →
Conditions studied
- Hypersensitivity — all drugs for Hypersensitivity →
Sponsor
University of Florida
Who can join
Adults 18 to 50, any sex, with Hypersensitivity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02588326
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02588326 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Florida
- Last refreshed: 16 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02588326.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing