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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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.
- Healthy subjects aged 18-45 (both inclusive) with an appropriate ratio of male tofemale.
- 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.
- 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:
- Allergic to any ingredients of this product or excipients (sucrose, Hypromellose,Carbomer 934P, Tartrazine aluminium lake, menthol,Magnesium octadecanoate, Povidone K
- Pregnant or breastfeeding women
- Participants with abnormal salivary secretion, such as patients with xerostomia anddiabetic dry mouth
- Usage of oral stimulants, salivary gland stimulants, other treatments or salivasubstitute treatment that may affect salivary gland secretion within 7 days beforescreening
- Those who cannot tolerate venipuncture or have a history of haemorrhage or needlefainting
- 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
- Those who indicated as abnormal with clinical significance in screening laboratoryexamination, physical examination, vital signs or electrocardiogram inspection basedon judgement of clinical study doctor.
- 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
Connect with a study center
Peking University People's Hospital
Beijing, Beijing 101149
ChinaSite Not Available
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