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

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 - CS0353-200147

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51112

Enrollment

Registered

2020-12-31

Start date

2021-05-11

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

The following IP will be used for this study: * Test Product: CPC/benzocaine 1.4 mg/10 mg sugar-free lozenge. A round, colourless biconvex lozenge with an S-shaped symbol on both sides. * Reference P

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To confirm that the dissolution profiles of a sugarfree and sugared lozenge containing CPC/benzocaine (1.4 mg/10 mg) are comparable following single dose in healthy adult subjects.	—

Secondary

Measure	Time frame
To determine the safety and local tolerability of the CPC/benzocaine (1.4 mg/10 mg) sugar-free and sugared lozenge. To determine the oral dissolution duration of the CPC/benzocaine (1.4 mg/10 mg) sugar-free and sugared lozenge.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)