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NCT01121354 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX
A Phase 1 study of Infection, sponsored by B. Braun Medical.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01121354: Completed Phase 1 study of Infection, sponsored by B. Braun Medical.
NCT01121354 is a Phase 1 study of Infection that has completed, run by B. Braun Medical. The registered enrollment target is 24 participants, below the 726-participant average among 41 other Infection trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01121354, a Phase 1 study of Infection, has completed, sponsored by B. Braun Medical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin 1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult subjects for 11 days of administration.
Primary Outcome
The primary objective is to evaluate the pharmacokinetics of an intravenous infusion of Cefazolin 2g for injection USP and Dextrose injection USP in healthy adult subjects at an infusion rate of 50 ml over 15 minutes, and Cefazolin 1.5g for injection USP and Dextrose injection USP in a similar population of healthy adult subjects.
Conditions Studied
Interventions
- DRUG Cefazolin 2g for Injection USP and Dextrose Injection USP
- DRUG Cefazolin 1.5g
Study Locations (1)
Maryland
- PAREXEL Early Phase Clinical Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
What the finished NCT01121354 record still lists
NCT01121354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 726-participant average among 41 other Infection trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Infection appearing as the primary indexed condition, and to 2 interventions - of which Cefazolin 2g for Injection USP and Dextrose Injection USP is the first listed.
NCT01121354 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01121354 about?
NCT01121354 is a clinical study titled "Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX". The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin 1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult subjects for 11 days of ad...
What is the current status of trial NCT01121354?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-12. Estimated completion is 2010-02.
What conditions does trial NCT01121354 study?
This clinical trial studies the following conditions: Infection.
What interventions are being tested in trial NCT01121354?
The interventions under investigation include: Cefazolin 2g for Injection USP and Dextrose Injection USP (DRUG), Cefazolin 1.5g (DRUG).
Who is sponsoring clinical trial NCT01121354?
This trial is sponsored by B. Braun Medical, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01121354 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01121354's enrollment target sits among peer trials
24 36th of 41 higher than 6 of 41 other Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infection 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.
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