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Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

Primary Purpose

Pharyngitis Acute, Gingivitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cetylpyridinium Chloride Buccal Tablets
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngitis Acute focused on measuring salivary drug concentration

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Peking University People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational group

Arm Description

Outcomes

Primary Outcome Measures

Salivary plasma drug concentration
Detecting the salivary drug concentration after dosing

Secondary Outcome Measures

Total salivary volume
Collecting the total salivary volume

Full Information

First Posted
March 26, 2023
Last Updated
July 10, 2023
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05802628
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
April 18, 2023 (Actual)
Study Completion Date
April 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis Acute, Gingivitis
Keywords
salivary drug concentration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cetylpyridinium Chloride Buccal Tablets
Intervention Description
Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet
Primary Outcome Measure Information:
Title
Salivary plasma drug concentration
Description
Detecting the salivary drug concentration after dosing
Time Frame
15 minutes, 0.5 hour, 1 hour, 1.5 hours, 2 hours after dosing
Secondary Outcome Measure Information:
Title
Total salivary volume
Description
Collecting the total salivary volume
Time Frame
The total salivary volume at the same time point on Day 0 and Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

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