Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

Peking University

Status and phase: Completed; Phase 4

Conditions: Pharyngitis Acute; Gingivitis

Treatments: Drug: Cetylpyridinium Chloride Buccal Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05802628

MLD-C-23001

Details and patient eligibility

About

The study is a single-arm, open-label study to explore the salivary concentration of Cetylpyridinium Chloride Buccal Tablets after single-dose administration in Healthy Subjects

Full description

Primary Objective: To observe the concentration of the investigational product in the saliva of healthy subjects.

Secondary purpose: To observe the safety of the investigational product in healthy subjects.

Enrollment: 10 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects who have fully understand the objective, character, methods and potential adverse reactions of the trial, voluntarily participate in the study, and sign the informed consent form before enrolled into the study.
2. Healthy subjects aged 18-45 (both inclusive) with an appropriate ratio of male to female.
3. Subjects who had no parenthood plan from the signing of the informed consent form to one month after completing study, and agreed to take effective and appropriate contraceptive measures voluntarily by themselves and their partners during this period.
4. Subjects those who be able to communicate well with investigators, and be able to understand and comply with the requirements of this study.

Exclusion criteria

1. Allergic to any ingredients of this product or excipients (sucrose, Hypromellose, Carbomer 934P, Tartrazine aluminium lake, menthol,Magnesium octadecanoate, Povidone K 30)
2. Pregnant or breastfeeding women
3. Participants with abnormal salivary secretion, such as patients with xerostomia and diabetic dry mouth
4. Usage of oral stimulants, salivary gland stimulants, other treatments or saliva substitute treatment that may affect salivary gland secretion within 7 days before screening
5. Those who cannot tolerate venipuncture or have a history of haemorrhage or needle fainting
6. Those who on special diet, who cannot comply with the standard diet of the study center, who have difficulty swallowing, who are lactose intolerant, or who have galactosemia or glucose/galactose absorption disorders
7. Those who indicated as abnormal with clinical significance in screening laboratory examination, physical examination, vital signs or electrocardiogram inspection based on judgement of clinical study doctor.
8. The subjects may not be able to complete the study following protocol due to other reasons or investigators judge that they are not suitable participants.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Investigational group

Experimental group

Treatment:

Drug: Cetylpyridinium Chloride Buccal Tablets