A Pharmacodynamic and Safety Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The changes of aerobic bacterial colonization in oropharyngeal
Study Overview
Brief Summary
To compare pharmacodynamics among the different concentrations of BCS and NS.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
low concentration Benzalkonium Chloride
To use low concentration Benzalkonium Chloride Solution to gargle
Intervention: Benzalkonium Chloride Solution (Drug)
high concentration Benzalkonium Chloride
To use high concentration Benzalkonium Chloride Solution to gargle
Intervention: Benzalkonium Chloride Solution (Drug)
Normal Saline
To use Normal Saline to gargle
Intervention: Benzalkonium Chloride Solution (Drug)
Outcomes
Primary Outcomes
The changes of aerobic bacterial colonization in oropharyngeal
Time Frame: 24 hours
To collect the throat swab samples and supragingival plaque samples before and post administration, respectively, a total of 11 time points.
Secondary Outcomes
- The improvement of oral healthy status(24 hours)
- The volunteers' feelings(24 hours)