Trials / Completed
CompletedNCT04184271
Pharmacokinetics of Advantage Arrest
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Advantage Silver Dental Arrest, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.
Detailed description
The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC, and total urinary recovery) to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 38% silver diamine fluoride | Topical application of SDF to teeth |
Timeline
- Start date
- 2017-08-01
- Primary completion
- 2017-09-30
- Completion
- 2019-03-31
- First posted
- 2019-12-03
- Last updated
- 2021-01-26
- Results posted
- 2020-08-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04184271. Inclusion in this directory is not an endorsement.