Healthy Subjects
Conditions
Brief summary
Single usage, open label study in up to 40 adult healthy males. Eligible subjects will receive a single usage of the investigational or commercial device. Retention of the radiolabeled device will be monitored using gamma scintigraphy.
Interventions
5 mls of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane
DEVICEMoi-Stir
2 sprays (0.35 mL) of the radiolabeled commercial device. A blend of Water, sorbitol, carboxymethylcellulose, sodium, methylparaben, propylparaben, potassium chloride, dibasic sodium phosphate, calcium chloride, magnesium chloride, sodium chloride, flavor.
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Refrain from nasal, throat, or lung inhalants and exercise for 24 hour prior to the test * Are able to tolerate the procedure and * Be generally healthy
Exclusion criteria
* Have history of allergy or hypersensitivity to the study ingredients * Major diseases * Taking medication regularly * Radiation exposure recently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve for volume of investigational device retained in the oral cavity. | 60 minutes |
Countries
United States
Outcome results
None listed