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

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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