An open-label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, oral dissolution study to assess sugar free and sugared cetylpyridinium chloride (CPC-1.4mg) and benzocaine (10mg) lozenges in healthy subjects

Completed

Conditions: temporary supportive treatment in painful inflammations of the mucosa of the mouth and throat (sore throat).
sore throat

Registration Number: NL-OMON51112

Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited (RB)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

Subject has provided written informed consent.
Subject is male or female and aged: 18 years to 55 years.
Subject has a Body Mass Index (BMI) of * 18.5 and * 30.0 kg / m2
Subject is healthy and free of clinically significant abnormal findings as
determined by medical history, physical examination and vital signs.

Exclusion Criteria

Female subject who is pregnant as confirmed by a positive pregnancy test or is
lactating.
Subject has a current and previous clinically significant medical history as
deemed by the Investigator including but not limited to cardiovascular,
salivary gland disorders (e.g. xerostomia, Sjogren*s syndrome, drooling of
saliva, stones or infections), respiratory, gastro-intestinal (nausea or
vomiting), neurological, metabolic and psychiatric disorders.
Subject has oral mucosal damage (erythema/ulceration/induration) or presence of
clinically significant sore throat, gingivitis, or oral thrush.
Subjects with any oromucosal conditions or salivary gland conditions that
affect saliva production.
Subject has toothache, is intended to have dental surgery or teeth treatment
within 14 days prior to the first drug administration to end of study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To confirm that the dissolution profiles of a sugarfree and sugared lozenge<br /><br>containing CPC/benzocaine (1.4 mg/10 mg) are comparable following single dose<br /><br>in healthy adult subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the safety and local tolerability of the CPC/benzocaine (1.4 mg/10<br /><br>mg) sugar-free and sugared lozenge.<br /><br>To determine the oral dissolution duration of the CPC/benzocaine (1.4 mg/10 mg)<br /><br>sugar-free and sugared lozenge.</p><br>