NCT00780286CompletedPhase 1
Retention of an Orally Administered Investigational Device vs Commerical Device in the Oral Cavity and Oropharynx of Healthy Human Male Volunteers
Procter and Gamble2 sites in 1 country32 target enrollmentStarted: October 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Area under the curve for volume of investigational device retained in the oral cavity.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Experimental
Intervention: Polymer based lubricating liquid (Device)
2
Active Comparator
Intervention: Moi-Stir (Device)
Outcomes
Primary Outcomes
Area under the curve for volume of investigational device retained in the oral cavity.
Time Frame: 60 minutes
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
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