Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy

Healthy Subjects Clinical Trial

Official title:

Retention of an Orally Administered Investigational Device in the Oropharynx of Healthy Human Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754091
• Other study ID #: 2008046
• Status: Completed
• Phase: Phase 1
• Start date: June 2008
• Est. completion date: June 2008

Study information

• Verified date: March 2019
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• Polymer based lubricating liquid
three sprays of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane

Locations

Country	Name	City	State
United States	Walter J Doll, PhD, RPh	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve for the percent of the mucoadhesive liquid retained in the oropharynx		one hour