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Sensitivity of Pharmacokinetics to Differences in Particle Size Distribution of Suspension-based Nasal Sprays

NCT02588326 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-11-16

No results posted yet for this 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.

Conditions

Interventions

DRUG

Mometasone furoate drug formulation (MFF) 1

Mometasone furoate drug formulation (MFF) 1 will be administered by suspension-based nasal spray.

DRUG

Mometasone furoate drug formulation (MFF) 2

Mometasone furoate drug formulation (MFF) 2 will be administered by suspension-based nasal spray.

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2020-07-08
Completion
2021-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02588326 on ClinicalTrials.gov