Conditions: Healthy
Keywords: Pharmacokinetics Safety
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus. arm 2: 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).

Interventions: intervention 1: ertapenem intervention 2: ertapenem
Intervention descriptions: intervention 1: 1 gram IV bolus every 24 hours (q24h) for 3 days intervention 2: 1 gram 30 minute infusion q24h for 3 days

Protocol document: