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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Device: Polymer based lubricating liquid; Device: Moi-Stir

• Registration Number: NCT00780286
• Lead Sponsor: Procter and Gamble

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Polymer based lubricating liquid	-
2	Moi-Stir	-

Primary Outcome Measures

Name	Time	Method
Area under the curve for volume of investigational device retained in the oral cavity.	60 minutes

Trial Locations

Locations (1)

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