Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

Study Overview
=================
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.

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

Conditions
-----------------
Pharyngitis Acute, Gingivitis

Intervention / Treatment
-----------------
* Drug: Cetylpyridinium Chloride Buccal Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Healthy subjects aged 18-45 (both inclusive) with an appropriate ratio of male to female. 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. 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: Allergic to any ingredients of this product or excipients (sucrose, Hypromellose, Carbomer 934P, Tartrazine aluminium lake, menthol,Magnesium octadecanoate, Povidone K 30) Pregnant or breastfeeding women Participants with abnormal salivary secretion, such as patients with xerostomia and diabetic dry mouth Usage of oral stimulants, salivary gland stimulants, other treatments or saliva substitute treatment that may affect salivary gland secretion within 7 days before screening Those who cannot tolerate venipuncture or have a history of haemorrhage or needle fainting 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 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational group<br> | Drug: Cetylpyridinium Chloride Buccal Tablets<br>* Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary plasma drug concentration | Detecting the salivary drug concentration after dosing | 15 minutes, 0.5 hour, 1 hour, 1.5 hours, 2 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total salivary volume | Collecting the total salivary volume | The total salivary volume at the same time point on Day 0 and Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
salivary drug concentration