Clinical trial NCT05802628: Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets
Official title: A Single-arm, Open-label Study to Explore the Salivary Concentration of Cetylpyridinium Chloride Buccal Tablets After Single-dose Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharyngitis Acute
Gingivitis
Keywords: salivary drug concentration
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Salivary plasma drug concentration
timeFrame: 15 minutes, 0.5 hour, 1 hour, 1.5 hours, 2 hours after dosing
Secondary outcomes:
measure: Total salivary volume
timeFrame: The total salivary volume at the same time point on Day 0 and Day 1
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: