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Cefazolin PK Study 3g vs 2g

NCT05309304 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-10-12

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

Cefazolin

Cefazolin Injection - 2 g/100 mL or 3 g/150 mL

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2022-08-30
Completion
2022-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05309304 on ClinicalTrials.gov