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3 g cefazolin for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Baxter Healthcare Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (15 minutes prior to dosing as a baseline measurement and at 2, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300,360, 420, and 480 minutes post-dosing)
Awards & highlights

Study Summary

Study is to characterize the safety and tolerability of cefazolin after a single IV administration in healthy subjects in a 3 g/150 mL presentation to meet the increasing clinical need for the indication of perioperative prophylaxis in this patient population weighing greater than or equal to (≥) 120 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (15 minutes prior to dosing as a baseline measurement and at 2, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300,360, 420, and 480 minutes post-dosing)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (15 minutes prior to dosing as a baseline measurement and at 2, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300,360, 420, and 480 minutes post-dosing) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curve (AUC)
Maximum concentration (Cmax)
Number of subjects with Non-serious TEAEs
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 3 g cefazolinExperimental Treatment1 Intervention
Healthy adult subjects weighing ≥120 kg. (g=grams)
Group II: 2 g cefazolinActive Control1 Intervention
Healthy adult subjects weighing <120 kg. (g=grams)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cefazolin
2017
Completed Phase 4
~4720

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Baxter Healthcare CorporationLead Sponsor
315 Previous Clinical Trials
200,044 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Cefazolin PK Study 3g vs 2g
2022. "Cefazolin PK Study 3g vs 2g". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05309304.
~8 spots leftby Apr 2025
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