Phase 4
Completed N=12
Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion
Healthy
Source: ClinicalTrials.gov NCT01148771 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose) — 193.33; 165.70 mcg/mL
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.
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 | — |
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
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. Informational only — not medical advice.