A Pharmacodynamic and Safety Study of BCS in Healthy Volunteers

Study Overview
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Brief Summary
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To compare pharmacodynamics among the different concentrations of BCS and NS.

Detailed Description
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2 times mouthwash in the morning and at night. To collect bacterium samples to assess the pharmacodynamics among the different concentrations of BCS and NS: observe the changes of aerobic bacterial colonization in oropharyngeal over time during 24 hours, and assess the improvement of oral healthy status and the subjective feelings after 24 hours.

Official Title
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A Pharmacodynamic and Safety Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Benzalkonium Chloride Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers, males or females. Females with U-HCG negative. Signed ICFs, and could conduct this study with investigators. Exclusion Criteria: History of mouthwash allergies, allergic rhinitis or dermatitis. Volunteers with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer. Volunteers with removable denture. Had received special oral clean.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low concentration Benzalkonium Chloride<br>To use low concentration Benzalkonium Chloride Solution to gargle | Drug: Benzalkonium Chloride Solution<br>* To compare pharmacodynamics among the different concentrations of BCS and NS<br>* Other names: Youkeshi;|
| Active Comparator: high concentration Benzalkonium Chloride<br>To use high concentration Benzalkonium Chloride Solution to gargle | Drug: Benzalkonium Chloride Solution<br>* To compare pharmacodynamics among the different concentrations of BCS and NS<br>* Other names: Youkeshi;|
| Placebo Comparator: Normal Saline<br>To use Normal Saline to gargle | Drug: Benzalkonium Chloride Solution<br>* To compare pharmacodynamics among the different concentrations of BCS and NS<br>* Other names: Youkeshi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of aerobic bacterial colonization in oropharyngeal | To collect the throat swab samples and supragingival plaque samples before and post administration, respectively, a total of 11 time points. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of oral healthy status | To use Plaque Index (PLI) to reflect volunteers' oral healthy status. | 24 hours | 
| The volunteers' feelings | The feelings including: comfortable, general comfortable, uncomfortable. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacodynamic Study of BCS