MedTrace Logo

A Novel Mouthwash Formulation CTP/BNZ With Mucus Adhesive Polymer

NCT03706781 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-08-05

No results posted yet for this study

Summary

The purpose of the study is to evaluate the local tolerability and the systemic availability of benzydamine, if any, after single and multiple dose treatment with the test formulation containing cetylpyridinium chloride 0.05% + benzydamine hydrochloride 0.15% + mucoadhesive polymer and with the reference formulation Tantum Verde Bocca containing cetylpyridinium chloride 0.05% + benzydamine hydrochloride 0.15% to healthy subjects , under fasting conditions, in two consecutive study periods.

Conditions

  • Healthy

Interventions

DRUG

Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer

Test product will be applied twice a day (b.i.d) every 12 h once in the morning and once in the evening for 6 consecutive days (from Day 1 to Day 6) and once in the morning on Day 7 for a total of 13 dose

DRUG

Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15%

Reference Product will be applied twice a day (b.i.d) every 12 h once in the morning and once in the evening for 6 consecutive days (from Day 1 to Day 6) and once in the morning on Day 7 for a total of 13 dose

Sponsors & Collaborators

  • Cross Research S.A.

    collaborator INDUSTRY

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Principal Investigators

  • Milko Radicioni · Cross Research S.A.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2017-12-18
Completion
2018-03-30

Countries

  • Switzerland

Study Locations

More Related Trials

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 NCT03706781 on ClinicalTrials.gov