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

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

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.

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