NCT05802628

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

8 days

First QC Date

March 26, 2023

Last Update Submit

July 10, 2023

Conditions

Pharyngitis AcuteGingivitis

Keywords

salivary drug concentration

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Total salivary volume

    The total salivary volume at the same time point on Day 0 and Day 1

Study Arms (1)

Investigational group

EXPERIMENTAL
Drug: Cetylpyridinium Chloride Buccal Tablets

Interventions

Cetylpyridinium Chloride Buccal TabletsDRUG

Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet

Investigational group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 101149, China

Location

Related Publications (1)

  • 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.

    PMID: 37985697DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pharmacy

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 6, 2023

Study Start

April 10, 2023

Primary Completion

April 18, 2023

Study Completion

April 18, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)