A Pharmacodynamic and Safety Study of BCS in Healthy Volunteers

Lustre Pharmaceuticals

Status and phase: Unknown; Phase 4

Conditions: Healthy Volunteers

Treatments: Drug: Benzalkonium Chloride Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02594449

LC-PHB1505

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 3 patient groups, including a placebo group

low concentration Benzalkonium Chloride

Active Comparator group

Description:

To use low concentration Benzalkonium Chloride Solution to gargle

Treatment:

Drug: Benzalkonium Chloride Solution

high concentration Benzalkonium Chloride

Active Comparator group

Description:

To use high concentration Benzalkonium Chloride Solution to gargle

Treatment:

Drug: Benzalkonium Chloride Solution

Normal Saline

Placebo Comparator group

Description:

To use Normal Saline to gargle

Treatment:

Drug: Benzalkonium Chloride Solution