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NCT03331263 · ClinicalTrials.gov registry record · Phase 1

Single Dose CHG Pharmacokinetic Study

A Phase 1 study, sponsored by Medline Industries.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT03331263: Completed Phase 1 study, sponsored by Medline Industries.

NCT03331263 is a Phase 1 study that has completed, run by Medline Industries. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03331263, a Phase 1 study, has completed, sponsored by Medline Industries.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Chlorhexidine Gluconate

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2017-07-21
Est. Completion 2017-08-06
Phase Phase 1
Medline Industries

24 total trials

What the finished NCT03331263 record still lists

NCT03331263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which Chlorhexidine Gluconate is the first listed.

NCT03331263 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03331263 about?

NCT03331263 is a clinical study titled "Single Dose CHG Pharmacokinetic Study". 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 t...

What is the current status of trial NCT03331263?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-07-21. Estimated completion is 2017-08-06.

What interventions are being tested in trial NCT03331263?

The interventions under investigation include: Chlorhexidine Gluconate (DRUG).

Who is sponsoring clinical trial NCT03331263?

This trial is sponsored by Medline Industries, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03331263's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03331263, the US trial registry maintained by the National Library of Medicine. NCT03331263 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.