The primary objective of this study is to confirm that the dissolution profiles of a sugar-free and sugared lozenge containing CPC/benzocaine (1.4mg/10 mg) are comparable following a single dose in healthy adult subjects.The secondary objectives of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
temporary supportive treatment in painful inflammations of the mucosa of the mouth and throat (sore throat).
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
RB has developed a sugar-free lozenge containing the same active pharmaceutical
ingredients (API) as the sugared lozenge but with new
excipients, with an aim of replacing the sugared formula on the market to
expand the patient group to those patients who cannot, or do not wish to
take a lozenge containing sugar. It is important to understand whether the
change in excipients affects the local availability of the APIs (CPC and
benzocaine). This clinical study has been designed to evaluate the similarity
of the dissolution profiles by comparing the weight loss of the CPC/benzocaine
sugar-free and sugared lozenges over time.
Study objective
The primary objective of this study is to confirm that the dissolution profiles
of a sugar-free and sugared lozenge containing CPC/benzocaine (1.4
mg/10 mg) are comparable following a single dose in healthy adult subjects.
The secondary objectives of this study, are as follows:
* 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 (1.4mg/10
mg) sugar-free and sugared lozenge.
Study design
This is an open label, single-dose, randomised, two-period, two-treatment,
twosequence, crossover, local availability study.
Subjects will attend the Clinical Unit on two occasions; Screening Visit and
Dosing Period Visit (which consists of two dosing days * Dosing Day 1 and
Dosing Day 2), after which subjects will receive a follow-up telephone call
after the dosing period.
Intervention
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 Product: CPC/benzocaine 1.4 mg/10 mg sugared lozenge. A round,
green biconvex lozenge with an S-shaped symbol on both sides (Marketing
Authorisation Number 4974.00.00).
Study burden and risks
Since the study is being executed in healthy volunteers, there are no
anticipated benefits of the IMP. Please see the IB for further
information.
Dansom Lane Dansom Lane
Kingston upon Hull HU8 7DS
GB
Dansom Lane Dansom Lane
Kingston upon Hull HU8 7DS
GB
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-004729-22-NL |
| CCMO | NL76074.056.20 |