Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

Gingivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05802628
• Other study ID #: MLD-C-23001
• Status: Completed
• Phase: Phase 4
• Start date: April 10, 2023
• Est. completion date: April 18, 2023

Study information

• Verified date: July 2023
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 18, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Pharyngitis
• Pharyngitis Acute

Intervention

Drug:
• Cetylpyridinium Chloride Buccal Tablets
Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total salivary volume	Collecting the total salivary volume	The total salivary volume at the same time point on Day 0 and Day 1