A Phase 1 interventional study of Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer and Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% in Healthy, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A · Phase 1, Interventional, and Other
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.
Aziende Chimiche Riunite Angelini Francesco S.p.A is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
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Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception:
For all women, pregnancy test result must be negative at screening.
Exclusion Criteria:
A multiple dose of the Cetylpyridinium Chloride 0.05%+Benzydamine HCl 0.15% (CTP/BNZ) + mucus adhesive polymer is administered to healthy subjects twice a day for 7 days, under fasting conditions in two subsequent periods according to the randomised cross-over design.
Drug: Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer
A multiple dose of the Cetylpyridinium Chloride 0.05%+Benzydamine HCl 0.15% (CTP/BNZ) Tantum Verde Bocca is administered to healthy subjects twice a day for 7 days, under fasting conditions in two subsequent periods according to the randomised cross-over design.
Drug: Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15%
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
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
Also known as: Tantum verde bocca
Change in Local Adverse Reactions (ADRs)
Local ADRs reported by the subjects through a 4-point scale according to a local tolerability scale (degree of severity of reactions from 0 to 3. 0=none; 1=mild 2= moderate; 3= severe) as 0-3 scores for burning sensation, irritation, pruritus, dry mouth, salivary hypersecretion and dysphagia. If the score assigned will be 1, 2 or 3, the local AE will classified as a TEAE of mild, moderate or severe severity, respectively.
Time frame: Change before and after each administration up to Day 8
Systemic availability of benzydamine (free base) through Cmax.
Systemic availability of benzydamine (free base) by measurement of plasma concentrations.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 h after the first dose. Days 7-8: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24 h after the last dose.
Systemic availability of benzydamine (free base) through AUC(0-t).
Systemic availability of benzydamine (free base) by measurement of area under the plasma concentration-time curve \[AUC(0-t)\].
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 h after the first dose. Days 7-8: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24 h after the last dose.
Incidence of AEs
General tolerability and safety of the study products assessed through monitoring of AEs including clinically significant abnormalities in laboratory assays (haematology, blood chemistry, urinalysis).
Time frame: Through study completion, an average of three weeks
Palatability
Organoleptic properties of the study products evaluated through a ORGANOLEPTIC AND EASE OF USE CHARACTERISTICS questionnaire.
Time frame: Day 7 (after the last dose of each study period).
Plan to share: Undecided
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Aziende Chimiche Riunite Angelini Francesco S.p.A