NCT04186663

Pharmacokinetics of Advantage Arrest in Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Advantage Silver Dental Arrest, LLC · Industry
• Sex: All
• Age: 3 Years – 13 Years
• Healthy volunteers: Accepted

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).

Detailed description

This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest. This is an open label exposure-response study with up to 50 healthy children ages 3-13 years of age. Subjects will be treated with Advantage Arrest and have one blood sample withdrawn at a randomly assigned time point. A minimum of 3 subjects per time point at 2,4,6,24,48,96 and 168 hours. Serum samples will be analyzed for F and Ag.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	Silver Diamine Fluoride	38% aqueous silver diamine fluoride \[Ag(NH3)\]2F, CAS RN 33040-28-7

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2019-12-05
• Last updated: 2022-03-10
• Results posted: 2022-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study