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

Information source: Hartford Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: ertapenem (Drug); ertapenem (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hartford Hospital

Official(s) and/or principal investigator(s):
Josepth L Kuti, PharmD, Principal Investigator, Affiliation: Hartford Hospital
Dora E Wiskirchen, PharmD, Study Director, Affiliation: Hartford Hospital


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.

Clinical Details

Official title: Comparative Pharmacokinetics, Safety, and Pharmacodynamics of Ertapenem 1 Gram Daily Administered as an IV Bolus Versus Standard 30 Minute Infusion to Healthy Adult Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)

Area Under the Curve From 48 to 72 Hours [AUC(48-72)]

Secondary outcome:

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Probability of Target Attainment (PTA)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Healthy adults (18 years of age or older)

Exclusion Criteria:

- 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

Locations and Contacts

Hartford Hospital, Hartford, Connecticut 06102, United States
Additional Information

Starting date: August 2010
Last updated: April 13, 2012

Page last updated: August 23, 2015

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