Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

Last updated: July 10, 2023
Sponsor: Peking University People's Hospital
Overall Status: Completed

Phase

4

Condition

Pharyngitis

Periodontitis

Treatment

Cetylpyridinium Chloride Buccal Tablets

Clinical Study ID

NCT05802628
MLD-C-23001
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects who have fully understand the objective, character, methods and potentialadverse reactions of the trial, voluntarily participate in the study, and sign theinformed consent form before enrolled into the study.
  2. Healthy subjects aged 18-45 (both inclusive) with an appropriate ratio of male tofemale.
  3. Subjects who had no parenthood plan from the signing of the informed consent form toone month after completing study, and agreed to take effective and appropriatecontraceptive measures voluntarily by themselves and their partners during thisperiod.
  4. Subjects those who be able to communicate well with investigators, and be able tounderstand and comply with the requirements of this study.

Exclusion

Exclusion Criteria:

  1. Allergic to any ingredients of this product or excipients (sucrose, Hypromellose,Carbomer 934P, Tartrazine aluminium lake, menthol,Magnesium octadecanoate, Povidone K
  1. Pregnant or breastfeeding women
  2. Participants with abnormal salivary secretion, such as patients with xerostomia anddiabetic dry mouth
  3. Usage of oral stimulants, salivary gland stimulants, other treatments or salivasubstitute treatment that may affect salivary gland secretion within 7 days beforescreening
  4. Those who cannot tolerate venipuncture or have a history of haemorrhage or needlefainting
  5. Those who on special diet, who cannot comply with the standard diet of the studycenter, who have difficulty swallowing, who are lactose intolerant, or who havegalactosemia or glucose/galactose absorption disorders
  6. Those who indicated as abnormal with clinical significance in screening laboratoryexamination, physical examination, vital signs or electrocardiogram inspection basedon judgement of clinical study doctor.
  7. The subjects may not be able to complete the study following protocol due to otherreasons or investigators judge that they are not suitable participants.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Cetylpyridinium Chloride Buccal Tablets
Phase: 4
Study Start date:
April 10, 2023
Estimated Completion Date:
April 18, 2023

Study 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.

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 101149
    China

    Site Not Available

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