A Pharmacodynamic and Safety Study of BCS in Healthy Volunteers

Phase 4

• Conditions: Healthy Volunteers
• Interventions: Drug: Benzalkonium Chloride Solution

• Registration Number: NCT02594449
• Lead Sponsor: Lustre Pharmaceutical Lab Co., Ltd

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 Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-11-02
• Last Update Submitted: 2015-11-02
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03
• Primary Completion: 2016-01
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high concentration Benzalkonium Chloride	Benzalkonium Chloride Solution	To use high concentration Benzalkonium Chloride Solution to gargle
low concentration Benzalkonium Chloride	Benzalkonium Chloride Solution	To use low concentration Benzalkonium Chloride Solution to gargle
Normal Saline	Benzalkonium Chloride Solution	To use Normal Saline to gargle

Primary Outcome Measures

Name	Time	Method
The changes of aerobic bacterial colonization in oropharyngeal	24 hours	To collect the throat swab samples and supragingival plaque samples before and post administration, respectively, a total of 11 time points.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China