MedTrace Logo

Pharmacokinetics of Advantage Arrest in Children

NCT04186663 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2022-03-10

Study results available
· View outcomes & findings →

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).

Conditions

  • Dental Caries

Interventions

DRUG

Silver Diamine Fluoride

38% aqueous silver diamine fluoride \[Ag(NH3)\]2F, CAS RN 33040-28-7

Sponsors & Collaborators

Principal Investigators

  • Hellene Ellenikiotis, DDS · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-03-31
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04186663 on ClinicalTrials.gov