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Single Dose CHG Pharmacokinetic Study

NCT ID: NCT03331263

Last Updated: 2023-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-21

Study Completion Date

2017-08-06

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Skin Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
laboratory-blinded, 3-period, 3-sequence, crossover study

Study Groups

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Abdominal application of 2% CHG

Group Type EXPERIMENTAL

Chlorhexidine Gluconate

Intervention Type DRUG

2% CHG

Groin application of 2% CHG

Group Type EXPERIMENTAL

Chlorhexidine Gluconate

Intervention Type DRUG

2% CHG

Control treatment with no application

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chlorhexidine Gluconate

2% CHG

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medline Industries

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Carlson, Pharm D.

Role: PRINCIPAL_INVESTIGATOR

Algorithme Pharma USA LLC

Locations

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Algorithme Pharma USA LLC

Fargo, North Dakota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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R17-023

Identifier Type: -

Identifier Source: org_study_id