Pharyngitis AcutePhase 4NCT05802628
Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets
A Phase 4 study testing Cetylpyridinium Chloride Buccal Tablets in people with Pharyngitis Acute and Gingivitis, run by Peking University People's Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharyngitis Acute, Gingivitis
- What is being tested?
- Cetylpyridinium Chloride Buccal Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2023to 18 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 101149
About this study
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
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.
- Conditions
- Pharyngitis Acute, Gingivitis
- Being tested
- Cetylpyridinium Chloride Buccal Tablets
- Keywords
- salivary drug concentration
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetylpyridinium Chloride Buccal TabletsDrug
Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet
| Study group | Role | What they receive |
|---|---|---|
| Investigational group | Experimental | Not described Receives: Drug: Cetylpyridinium Chloride Buccal Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary plasma drug concentration
Detecting the salivary drug concentration after dosing
Measured: 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
Measured: The total salivary volume at the same time point on Day 0 and Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start10 Apr 2023
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharyngitis AcuteStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Fang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802628
- Sponsor's protocol ID
- MLD-C-23001
- Status last verified
- Jul 2023
- First submitted
- 26 Mar 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05802628
- Acronym / sponsor ID
- MLD-C-23001
- Conditions
- Pharyngitis Acute, Gingivitis
- Keywords
- salivary drug concentration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational group | Experimental | Drug: Cetylpyridinium Chloride Buccal Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetylpyridinium Chloride Buccal TabletsSubjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet | Drug | Investigational group |
Primary outcome
Salivary plasma drug concentration
Time frame: 15 minutes, 0.5 hour, 1 hour, 1.5 hours, 2 hours after dosing
Detecting the salivary drug concentration after dosing
1 secondary outcome
Total salivary volume
Time frame: The total salivary volume at the same time point on Day 0 and Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Derived from this study: PubMed 37985697Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetylpyridinium Chloride Buccal Tablets in people with Pharyngitis Acute and Gingivitis, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary plasma drug concentration (time frame: 15 minutes, 0.5 hour, 1 hour, 1.5 hours, 2 hours after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.