Salivary Drug Concentration Exploratory Study of Cetylpyr... | NCT05802628

Studies
Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

NCT05802628

Sponsor

Peking University People's Hospital

Status

Completed

Last Update Posted

Jul 12, 2023Actual

Enrollment

10Actual

Phase

Phase 4

Conditions

Pharyngitis Acute
Gingivitis

Interventions

Cetylpyridinium Chloride Buccal Tablets

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2023Actual

Primary Completion Date

Apr 18, 2023Actual

Completion Date

Apr 18, 2023Actual

First Submitted Date

Mar 26, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2023

Last Update Posted Date

Jul 12, 2023Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
Investigational group	Experimental		Drug: Cetylpyridinium Chloride Buccal Tablets

Name	Type	Description	Arm Group Labels	Other Names
Cetylpyridinium Chloride Buccal Tablets	Drug	Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet	Investigational group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's Hospital		Beijing	Beijing Municipality	101149	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37985697	Derived	Li Y, Xie Z, Chen L, Liu X, Li S, Ye S, Tang H, Lee C, Gu Q, Men F, Zhang J, Hu D, Jiang Y, Wang X, Wang Q, Feng Y, Niu S, Liu Y, Fang Y. An exploratory study of drug concentration and inhibitory effect of cetylpyridinium chloride buccal tablets on SARS-CoV-2 infection among 10 Chinese subjects. Fundam Clin Pharmacol. 2024 Jun;38(3):579-587. doi: 10.1111/fcp.12972. Epub 2023 Nov 20.

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases