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NCT01148771 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion
A Phase 4 study, sponsored by Hartford Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT01148771: Completed Phase 4 study, sponsored by Hartford Hospital.
NCT01148771 is a Phase 4 study that has completed, run by Hartford Hospital. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01148771, a Phase 4 study, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
Cmax is measured at 5 minutes after the beginning of the infusion for the 5 minute IV bolus dosage regimen and at 30 minutes after the beginning of the infusion for the 30 minute infusion dosage regimen.
Interventions
- DRUG ertapenem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-08 |
| Est. Completion | 2010-10 |
| Phase | Phase 4 |
What the finished NCT01148771 record still lists
NCT01148771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which ertapenem is the first listed.
NCT01148771 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01148771 about?
NCT01148771 is a clinical study titled "Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion". 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 ...
What is the current status of trial NCT01148771?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2010-08. Estimated completion is 2010-10.
What interventions are being tested in trial NCT01148771?
The interventions under investigation include: ertapenem (DRUG).
Who is sponsoring clinical trial NCT01148771?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01148771's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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