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Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers

NCT00797420 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-11-05

No results posted yet for this study

Summary

The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.

Conditions

  • Candidiasis

Interventions

DRUG

Fluconazole Loading Dose

Single Fluconazole loading dose 25 mg/kg

DRUG

Fluconazole Loading Dose & High Dose

Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days

Sponsors & Collaborators

  • Pediatric Pharmacology Research Units Network

    collaborator NETWORK

  • Daniel Benjamin

    lead OTHER

Principal Investigators

  • Daniel Benjamin, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
48 Hours
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-01-31
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00797420 on ClinicalTrials.gov