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

Hartford Hospital

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: ertapenem

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01148771

KUTI003194HE

IISP ID#37935 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12 participants in 2 patient groups

Ertapenem 1 gram intravenous (IV) 5 minute bolus

Experimental group

Description:

Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus.

Treatment:

Drug: ertapenem

Ertapenem 1 gram IV 30 minute infusion

Active Comparator group

Description:

Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 30 minute infusion (i.e., the standard dose).

Treatment:

Drug: ertapenem