Single Dose CHG Pharmacokinetic Study

• Status: Completed
• Trial end date: 2017-08-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medline Industries
• Treatments: Chlorhexidine; Chlorhexidine gluconate

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)