Phase 4 N=12 Randomized

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01148771 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose) — 193.33; 165.70 mcg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: ertapenem (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hartford Hospital
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)	193.33; 165.70	—
PRIMARY Area Under the Curve From 48 to 72 Hours [AUC(48-72)]	561.17; 531.32	—
SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability	10; 9	—
SECONDARY Probability of Target Attainment (PTA)	97.0; 97.9; 1.7; 2.8	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01148771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.