Gingivitis, Pharyngitis Acute
Conditions
Keywords
salivary drug concentration
Brief 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
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.
Interventions
DRUGCetylpyridinium Chloride Buccal Tablets
Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary plasma drug concentration | 15 minutes, 0.5 hour, 1 hour, 1.5 hours, 2 hours after dosing | Detecting the salivary drug concentration after dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total salivary volume | The total salivary volume at the same time point on Day 0 and Day 1 | Collecting the total salivary volume |
Countries
China
Outcome results
None listed