Pharmacokinetics of Advantage Arrest in Children

• Status: Completed
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy children to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Advantage Silver Dental Arrest, LLC
• Collaborator: University of California, San Francisco
• Treatments: Fluorides; Imidacloprid

Criteria

Inclusion Criteria:

• Healthy.

• At least one carious lesion.

Exclusion Criteria:

• Oral mucositis

• Any ulcerative lesions

• Hypersensitivity to silver

• Hypersensitivity to fluoride.

• SDF treatment within 3 months.