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Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion

NCT01148771 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-05-11

Study results available
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Summary

The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and compared.

Conditions

  • Healthy

Interventions

DRUG

ertapenem

1 gram IV bolus every 24 hours (q24h) for 3 days

DRUG

ertapenem

1 gram 30 minute infusion q24h for 3 days

Sponsors & Collaborators

Principal Investigators

  • Josepth L Kuti, PharmD · Hartford Hospital

  • Dora E Wiskirchen, PharmD · Hartford Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01148771 on ClinicalTrials.gov