NCT00780286

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

Retention of an Orally Administered Investigational Device vs Commerical Device in the Oral Cavity and Oropharynx of Healthy Human Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DEVICE	Polymer based lubricating liquid	5 mls of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane
DEVICE	Moi-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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-10-27
• Last updated: 2019-04-02

Locations

1 site across 1 country: United States