A Pharmacodynamic and Safety Study of BCS in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02594449
• Other study ID #: LC-PHB1505
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 29, 2015
• Last updated: November 2, 2015
• Start date: October 2015
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: Lustre Pharmaceutical Lab Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Benzalkonium Chloride Solution
To compare pharmacodynamics among the different concentrations of BCS and NS

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Lustre Pharmaceutical Lab Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The improvement of oral healthy status	To use Plaque Index (PLI) to reflect volunteers' oral healthy status.	24 hours	No
Secondary	The volunteers' feelings	The feelings including: comfortable, general comfortable, uncomfortable.	24 hours	Yes