NCT03706781

A Novel Mouthwash Formulation CTP/BNZ With Mucus Adhesive Polymer

A Phase I Study of a Novel Mouthwash Formulation (Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + Mucus - Adhesive Polymer) Administered Twice a Day for 7 Days to Healthy Subjects in Comparison With Marketed Tantum Verde Bocca Mouthwash Solution

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-11-14
• Primary completion: 2017-12-18
• Completion: 2018-03-30
• First posted: 2018-10-16
• Last updated: 2020-08-05

Locations

1 site across 1 country: Switzerland