A Pharmacodynamic and Safety Study of BCS in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-03-31

Brief Summary

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To compare pharmacodynamics among the different concentrations of BCS and NS.

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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low concentration Benzalkonium Chloride

To use low concentration Benzalkonium Chloride Solution to gargle

Group Type ACTIVE_COMPARATOR

Benzalkonium Chloride Solution

Intervention Type DRUG

To compare pharmacodynamics among the different concentrations of BCS and NS

high concentration Benzalkonium Chloride

To use high concentration Benzalkonium Chloride Solution to gargle

Group Type ACTIVE_COMPARATOR

Benzalkonium Chloride Solution

Intervention Type DRUG

To compare pharmacodynamics among the different concentrations of BCS and NS

Normal Saline

To use Normal Saline to gargle

Group Type PLACEBO_COMPARATOR

Benzalkonium Chloride Solution

Intervention Type DRUG

To compare pharmacodynamics among the different concentrations of BCS and NS

Interventions

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Benzalkonium Chloride Solution

To compare pharmacodynamics among the different concentrations of BCS and NS

Intervention Type DRUG

Other Intervention Names

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Youkeshi

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes