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Completed

NCT Number: NCT05802628

Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 101149, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cetylpyridinium Chloride Buccal Tablets

Drug

Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet

Primary outcomes

  1. 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

Secondary outcomes

  1. Total salivary volume

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

    Collecting the total salivary volume

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Single-arm, Open-label Study to Explore the Salivary Concentration of Cetylpyridinium Chloride Buccal Tablets After Single-dose Administration in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2023
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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