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NCT00493246 · ClinicalTrials.gov registry record · Phase 1

Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients

A Phase 1 study, sponsored by Mallinckrodt.

Completed
Registry status
Phase 1
Development phase
75
Enrollment target

NCT00493246: Completed Phase 1 study, sponsored by Mallinckrodt.

NCT00493246 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00493246, a Phase 1 study, has completed, sponsored by Mallinckrodt.

COMPLETED
Registry status
Phase 1
Development phase
75 participants
Enrollment target

Study Summary

We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is an important step in learning what the best dose of acetaminophen for children should be. We are also interested in learning about the safety of this medication when given to children.

Primary Outcome

Cmax: Maximum Plasma Concentration

Interventions

  • DRUG IV Acetaminophen

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2007-06
Est. Completion 2008-11
Phase Phase 1
Mallinckrodt

69 total trials

What the finished NCT00493246 record still lists

NCT00493246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).

The record links to 0 conditions, and to 1 intervention - of which IV Acetaminophen is the first listed.

NCT00493246 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00493246 about?

NCT00493246 is a clinical study titled "Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients". We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called p...

What is the current status of trial NCT00493246?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2007-06. Estimated completion is 2008-11.

What interventions are being tested in trial NCT00493246?

The interventions under investigation include: IV Acetaminophen (DRUG).

Who is sponsoring clinical trial NCT00493246?

This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00493246's enrollment target sits among peer trials

75 711th of 2000 higher than 1,276 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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Source: ClinicalTrials.gov NCT00493246, the US trial registry maintained by the National Library of Medicine. NCT00493246 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.