Sensitivity of Pharmacokinetics to Differences in Particle Size Distribution of Suspension-based Nasal Sprays
Public ClinicalTrials.gov record NCT02588326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of the Sensitivity of Pharmacokinetics to Differences in the Particle Size Distribution of Two Different Formulations of a Locally-acting Mometasone Furoate Suspension-based Nasal Spray
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02588326
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 20, 2018
- Primary completion
- Jul 7, 2020
- Completion
- Apr 15, 2021
- Last update posted
- Nov 15, 2021
2018 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Department of Pharmaceutics, University of Florida | Gainesville | Florida | 32610 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02588326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 15, 2021 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02588326 live on ClinicalTrials.gov.