Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

A Single-arm, Open-label Study to Explore the Salivary Concentration of Cetylpyridinium Chloride Buccal Tablets After Single-dose Administration in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Gingivitis; Pharyngitis Acute
• Intervention / Treatment: Drug: Cetylpyridinium Chloride Buccal Tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 101149
      • Peking university People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational group	Drug: Cetylpyridinium Chloride Buccal Tablets; Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): April 18, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: salivary drug concentration
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Pharyngitis; Anti-Infective Agents, Local; Anti-Infective Agents; Cetylpyridinium
• Other Study ID Numbers: MLD-C-23001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No