Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00754091

Enrollment

Registered

2008-09-17

Start date

2008-06-30

Completion date

2008-06-30

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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.

Interventions

DEVICEPolymer based lubricating liquid

three sprays of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame
Area under the curve for the percent of the mucoadhesive liquid retained in the oropharynx	one hour

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026