drugset / Trial / NCT03706781

A Novel Mouthwash Formulation CTP/BNZ With Mucus Adhesive Polymer

NCT03706781

Phase 1 Completed 26 enrolled Angelini Pharma Cross Research S.A. · collab
RandomizedCrossoverOpen-labelOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Benzydamine Unknown 0.15 %
Subject Cetylpyridinium Small molecule 0.05 %

Indications

No indication recorded.