Status:
COMPLETED
Single Dose CHG Pharmacokinetic Study
Lead Sponsor:
Medline Industries
Conditions:
Surgical Skin Preparation
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 procedu...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03331263
Start Date
July 21 2017
End Date
August 6 2017
Last Update
December 15 2023
Active Locations (1)
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1
Algorithme Pharma USA LLC
Fargo, North Dakota, United States, 58104