Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy

Procter and Gamble16 enrolled

Overview

Single usage, open label study in 16 adult healthy males. Eligible subjects will receive a single usage of the investigational device. Retention of the radiolabeled device will be monitored using gamma scintigraphy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

Polymer based lubricating liquidDEVICE

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

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 the percent of the mucoadhesive liquid retained in the oropharynx

Time frame: one hour

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.