Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy Study 2

Procter and Gamble32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

Polymer based lubricating liquidDEVICE

5 mls of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane

Moi-StirDEVICE

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Walter J Doll, PhD, RPh

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Area under the curve for volume of investigational device retained in the oral cavity.

Time frame: 60 minutes

Data from ClinicalTrials.gov

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