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

Phase 1

Completed

• Conditions: Hypersensitivity
• Interventions: Drug: Mometasone furoate drug formulation (MFF) 1; Drug: Mometasone furoate drug formulation (MFF) 2

• Registration Number: NCT02588326
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

For every subject in this research study the following procedures and scheduling will take place.

During the screening visit the inclusion and exclusion criteria will be reviewed to ensure the subject is appropriate for the study. A physical examination will be performed after the vital sign measurements are obtained. Also, nasal spray application training will be performed and tolerability to charcoal block will be determined.

Screening tests will be performed within 30 days of study visit 1 and no later than 2 days before study visit 1. There will be 2 study visits in addition to the screening visit, a minimum period of 7 days should lapse between the subsequent study visits but no more than 3 weeks. The total study duration for each subject will be about 4-7 weeks.

Blood sample collection

Blood samples will be drawn by inserting an indwelling catheter for blood sample collection. Blood samples will be taken approximately 15 minutes prior to the dosing of the product (pre-dose sample) and at approximately 5, 10, 15, 30, 45, 60 minutes, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post dosing. At each time point about 10 mL of blood sample will be collected via vacutainer tubes for plasma preparation and storage. At each study visit a total of approximately 160 mL blood will be collected, which makes a total of 320 mL of blood during study visits 1 and 2.

The total amount of blood drawn in this study, including the screening visit, will be 327 ml. Additionally, up to approximately 15 mL of blood may be drawn for medically needed additional assessments to follow up the screening results. Therefore, in total up to approximately 342 mL of blood may be drawn from each subject.

Study Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Study Start: 2018-09-21
• Primary Completion: 2020-07-08
• Study Completion: 2021-04-16
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MFF 1, then MFF 2	Mometasone furoate drug formulation (MFF) 2	Mometasone furoate drug formulation (MFF) 1 will be administered by suspension-based nasal spray. After a wash out period then Mometasone furoate drug formulation (MFF) 2 will be administered by suspension-based nasal spray. All formulations will be a 200 mcg single dose.
MFF 2, then MFF 1	Mometasone furoate drug formulation (MFF) 2	Mometasone furoate drug formulation (MFF) 2 will be administered by suspension-based nasal spray. After a wash out period then Mometasone furoate drug formulation (MFF) 1 will be administered by suspension-based nasal spray. All formulations will be a 200 mcg single dose.
MFF 1, then MFF 2	Mometasone furoate drug formulation (MFF) 1	Mometasone furoate drug formulation (MFF) 1 will be administered by suspension-based nasal spray. After a wash out period then Mometasone furoate drug formulation (MFF) 2 will be administered by suspension-based nasal spray. All formulations will be a 200 mcg single dose.
MFF 2, then MFF 1	Mometasone furoate drug formulation (MFF) 1	Mometasone furoate drug formulation (MFF) 2 will be administered by suspension-based nasal spray. After a wash out period then Mometasone furoate drug formulation (MFF) 1 will be administered by suspension-based nasal spray. All formulations will be a 200 mcg single dose.

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of mometasone furoate formulation 1	15 min pre-dose and 5, 10, 15, 30, 45, 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post-dose
Area under the plasma concentration versus time curve (AUC) of mometasone furoate formulation 2	15 min pre-dose and 5, 10, 15, 30, 45, 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of mometasone furoate formulation 1	15 min pre-dose and 5, 10, 15, 30, 45, 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post-dose
Peak Plasma Concentration (Cmax) of mometasone furoate formulation 2	15 min pre-dose and 5, 10, 15, 30, 45, 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post-dose

Trial Locations

Locations (1)

Department of Pharmaceutics, University of Florida; 🇺🇸 Gainesville, Florida, United States