Single Dose CHG Pharmacokinetic Study

Surgical Skin Preparation Clinical Trial

Official title:

Single Dose Pharmacokinetic Study to Assess the Systemic Exposure of Chlorhexidine From ReadyPrep® CHG (2% Chlorhexidine Gluconate Cloth)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331263
• Other study ID #: R17-023
• Status: Completed
• Phase: Phase 1
• Start date: July 21, 2017
• Est. completion date: August 6, 2017

Study information

• Verified date: April 2021
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 6, 2017
• Est. primary completion date: August 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Subjects were male or female, aged = 18 and = 60 years (inclusive). The main inclusion criteria were:

• non- or ex-smokers

• body mass index (BMI) =19.00 kg/m2 and =32.00 kg/m2 and a body weight = 55 kg

• negative pregnancy test for female subjects

• healthy according to medical history, complete physical examination (including vital signs and skin examination) and laboratory tests (general biochemistry, hematology and urinalysis)

Related Conditions & MeSH terms

• Surgical Skin Preparation

Intervention

Drug:
• Chlorhexidine Gluconate
2% CHG

Locations

Country	Name	City	State
United States	Algorithme Pharma USA LLC	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG.	A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment.	Up to 24 hours after product application
Secondary	Number of Subjects With of Treatment Emergent Adverse Events.	Number of subjects with treatment related adverse events as assessed by System Organ Class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA).	Up to 24 hours after product application, overall, up to 3 weeks