Single Dose CHG Pharmacokinetic Study
Single Dose Pharmacokinetic Study to Assess the Systemic Exposure of Chlorhexidine From ReadyPrep® CHG (2% Chlorhexidine Gluconate Cloth)
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2017
CompletedFirst Submitted
Initial submission to the registry
October 23, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedResults Posted
Study results publicly available
December 15, 2023
CompletedDecember 15, 2023
April 1, 2021
16 days
October 23, 2017
May 1, 2019
March 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Subjects With of Treatment Emergent Adverse Events.
Up to 24 hours after product application, overall, up to 3 weeks
Study Arms (3)
Abdominal application of 2% CHG
EXPERIMENTALGroin application of 2% CHG
EXPERIMENTALControl treatment with no application
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Algorithme Pharma USA LLC
Fargo, North Dakota, 58104, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Senior Regulatory Affairs Specialist
- Organization
- Medline Industries, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
James Carlson, Pharm D.
Algorithme Pharma USA LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- laboratory-blinded, 3-period, 3-sequence, crossover study
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2017
First Posted
November 6, 2017
Study Start
July 21, 2017
Primary Completion
August 6, 2017
Study Completion
August 6, 2017
Last Updated
December 15, 2023
Results First Posted
December 15, 2023
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share