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Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101

NCT06182267 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-01-02

No results posted yet for this study

Summary

Pharmacokinetic (PK) study of L-arginine after exaggerated oral use of the novel dentifrice product COL101 after repeated daily applications in healthy adult subjects.

Conditions

  • Caries,Dental

Interventions

DRUG

L Arginine

toothpaste

DRUG

Sodium Fluoride

toothpaste

Sponsors & Collaborators

  • Colgate Palmolive

    lead INDUSTRY

Principal Investigators

  • Irina Krause, RN, MSN · TKL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2023-12-22
Completion
2023-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06182267 on ClinicalTrials.gov