A Pharmacodynamic and Safety Study of BCS in Healthy Volunteers

November 2, 2015 updated by: Lustre Pharmaceutical Lab Co., Ltd

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: low concentration Benzalkonium Chloride
To use low concentration Benzalkonium Chloride Solution to gargle
Drug: Benzalkonium Chloride Solution
To compare pharmacodynamics among the different concentrations of BCS and NS
Other Names:
  • Youkeshi
Active Comparator: high concentration Benzalkonium Chloride
To use high concentration Benzalkonium Chloride Solution to gargle
Drug: Benzalkonium Chloride Solution
To compare pharmacodynamics among the different concentrations of BCS and NS
Other Names:
  • Youkeshi
Placebo Comparator: Normal Saline
To use Normal Saline to gargle
Drug: Benzalkonium Chloride Solution
To compare pharmacodynamics among the different concentrations of BCS and NS
Other Names:
  • Youkeshi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lustre Pharmaceutical Lab Co., Ltd

Investigators

  • Principal Investigator: Shiyue Li, Professor, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC-PHB1505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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