Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Device: Polymer based lubricating liquid

• Registration Number: NCT00754091
• Lead Sponsor: Procter and Gamble

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-07-09
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-17
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Polymer based lubricating liquid	-

Primary Outcome Measures

Name	Time	Method
Area under the curve for the percent of the mucoadhesive liquid retained in the oropharynx	one hour

Trial Locations

Locations (1)

Walter J Doll, PhD, RPh; 🇺🇸 Lexington, Kentucky, United States