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CompletedNCT05802628Updated Jul 12, 2023

Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

A Phase 4 interventional study of Cetylpyridinium Chloride Buccal Tablets in Pharyngitis Acute and Gingivitis, sponsored by Peking University People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-12.

Sponsored by Peking University People's Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Pharyngitis Acute
  • Gingivitis

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Keywords

  • salivary drug concentration
03

In context

Gingivitis

609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's enrollment of 10 is below the median of 63 across 494 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 603 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Investigational group

    Drug: Cetylpyridinium Chloride Buccal Tablets

Interventions

  • DrugCetylpyridinium Chloride Buccal Tablets

    Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet

06

What researchers measure

Primary outcomes

  1. Salivary plasma drug concentration

    Detecting the salivary drug concentration after dosing

    Time frame: 15 minutes, 0.5 hour, 1 hour, 1.5 hours, 2 hours after dosing

Secondary outcomes

  1. Total salivary volume

    Collecting the total salivary volume

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

07

Study locations

1 site
  • Peking University People's Hospital
    Beijing, Beijing Municipality 101149, China
08

References and documents

Publications

  • 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. PubMed 37985697 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05802628
Responsible party
Yi Fang (Professor of Pharmacy, Peking University People's Hospital) — Principal investigator
First posted
Apr 6, 2023
Start date
Apr 10, 2023
Primary completion
Apr 18, 2023
Completion
Apr 18, 2023
Last update
Jul 12, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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