A study to evaluate salivary profile of sugar free and sugared lozenge
Research type
Research Study
Full title
A randomised, pilot, open label, controlled, crossover, partial replicate design to assess the in vivo availability of cetylpyridinium chloride (CPC - 1.4 mg) and benzocaine (10 mg) from the sugar-free lozenge and marketed sugared lozenge in healthy subjects as measured by saliva concentration
IRAS ID
252156
Contact name
Ezanul Wahab
Contact email
Sponsor organisation
Reckitt Benckiser Healthcare (UK) Ltd
Eudract number
2018-003207-19
Duration of Study in the UK
0 years, 0 months, 25 days
Research summary
This study is being funded by Reckitt Benckiser. The purpose of this study is to determine the levels of active ingredients in the saliva of a marketed sugared throat lozenge and a newly developed sugar free throat lozenge. Both products contain the same active ingredients, cetylpyridinium chloride (an antiseptic) and benzocaine (a local anaesthetic) at the same dose level 1.4 mg CPC and 10 mg benzocaine. These active ingredients help to reduce the pain and inflammation associated with sore throat.
To help evaluate the salivary PK profile of the 2 products, saliva samples will be taken at specific times during the study after subjects have taken both products. The purpose of this is to measure how much of the active ingredients are present in the saliva at certain timepoints following product administration. This will help to determine as to whether removing the sugar from the product affects how much of the active ingredients are in the saliva or the time it takes for the active ingredients to be present in the saliva.
The intention is that by establishing the salivary PK profile of both products, this information will help to inform future studies of the test product.
24 subjects (healthy males and females) will be enrolled in order for 15 to complete the study.
The study will consist of a screening visit, 3 treatment visits (there will be at least 2 days between treatment visits), and one post study follow-up visit. Each treatment visit will include 1 overnight stay. The post study follow-up will take place 2 to 7 days after the final saliva collection in treatment period 3.
REC name
Wales REC 2
REC reference
18/WA/0283
Date of REC Opinion
12 Oct 2018
REC opinion
Further Information Favourable Opinion