NCT01148771

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ertapenem	1 gram IV bolus every 24 hours (q24h) for 3 days
DRUG	ertapenem	1 gram 30 minute infusion q24h for 3 days

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-06-22
• Last updated: 2012-05-11
• Results posted: 2012-05-11

Locations

1 site across 1 country: United States