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NCT01904357 · ClinicalTrials.gov registry record · Phase 1
Pediatric Cefazolin PK Study
A Phase 1 study, sponsored by B. Braun Medical.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01904357: Completed Phase 1 study, sponsored by B. Braun Medical.
NCT01904357 is a Phase 1 study that has completed, run by B. Braun Medical. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01904357, a Phase 1 study, has completed, sponsored by B. Braun Medical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The primary objective of this study is: • To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis. The secondary objectives of this study are: * To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with modeling data for adolescents aged 13-17 years (inclusive) and historical data from adults receiving a single 2g dose of cefazolin. * To assess the safety of a single dose of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.
Primary Outcome
To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.
Interventions
- DRUG Cefazolin 1 GM Injection
- DRUG Cefazolin 2 GM Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01904357 record still lists
NCT01904357 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Cefazolin 1 GM Injection is the first listed.
NCT01904357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01904357 about?
NCT01904357 is a clinical study titled "Pediatric Cefazolin PK Study". The primary objective of this study is: • To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis. ...
What is the current status of trial NCT01904357?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2013-03. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01904357?
The interventions under investigation include: Cefazolin 1 GM Injection (DRUG), Cefazolin 2 GM Injection (DRUG).
Who is sponsoring clinical trial NCT01904357?
This trial is sponsored by B. Braun Medical, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01904357's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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