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

Procter & Gamble (P&G)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Device: Moi-Stir; Device: Polymer based lubricating liquid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00780286

2008068

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

1

Experimental group

Treatment:

Device: Polymer based lubricating liquid

2

Active Comparator group

Treatment:

Device: Moi-Stir