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

Completed · Phase 4

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01148771

Run by

Hartford Hospital

People needed

12

Starts

2010-08-01

Expected to finish

2010-10-01

Last updated by the study team

2012-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults (18 years of age or older)

You may not qualify if…

• Ertapenem or other beta-lactam allergy
• Pregnant or breast feeding females
• Body Mass Index (BMI) greater than or equal to 30
• Abnormal lab values at baseline
• Hypertension
• Significant medical abnormality
• Regular alcohol consumption
• Significant nicotine use

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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