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Single Dose CHG Pharmacokinetic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331263
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Medline Industries

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.

Condition or disease Intervention/treatment Phase
Surgical Skin Preparation Drug: Chlorhexidine Gluconate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: laboratory-blinded, 3-period, 3-sequence, crossover study
Primary Purpose: Prevention
Official Title: Single Dose Pharmacokinetic Study to Assess the Systemic Exposure of Chlorhexidine From ReadyPrep® CHG (2% Chlorhexidine Gluconate Cloth)
Actual Study Start Date : July 21, 2017
Actual Primary Completion Date : August 6, 2017
Actual Study Completion Date : August 6, 2017


Arm Intervention/treatment
Experimental: Abdominal application of 2% CHG Drug: Chlorhexidine Gluconate
2% CHG

Experimental: Groin application of 2% CHG Drug: Chlorhexidine Gluconate
2% CHG

No Intervention: Control treatment with no application



Primary Outcome Measures :
  1. Number of subjects with plasma levels of chlorexidine following systemic exposure after a single topical application of CHG. [ Time Frame: Up to 24 hours after application ]
    A total of 12 blood samples will be collected (one tube of 6 mL each) in each study period and analyzed for plasma levels of chlorhexidine.


Secondary Outcome Measures :
  1. Number of subjects with of treatment emergent adverse events. [ Time Frame: Up to 24 hours after application ]
    Number of subjects with treatment related adverse events as assessed by System Organ Class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA).

  2. Number of subjects with of treatment emergent adverse events. [ Time Frame: Up to 24 hours after application ]
    Number of subjects with treatment related adverse events as assessed by Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331263


Locations
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United States, North Dakota
Algorithme Pharma USA LLC
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Medline Industries
Investigators
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Principal Investigator: James Carlson, Pharm D. Algorithme Pharma USA LLC
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Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT03331263    
Other Study ID Numbers: R17-023
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents