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Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration

NCT04122560 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-07-14

No results posted yet for this study

Summary

The pharmacokinetics of fluconazole are expected to be different in obese patients compared to non-obese patients. The investigators will determine fluconazole and free fluconazole concentrations in 16 obese patients and 8 healthy volunteers, who will receive oral and intravenous fluconazole in a semi-simultaneous design.

A full pharmacokinetic curve will be obtained until 48 hours after intravenous administration.

Conditions

  • Fluconazole
  • Candidiasis
  • Invasive Fungal Infections
  • Obesity

Interventions

DRUG

Fluconazole 200mg tab

PO dose of 400mg

DRUG

Fluconazole 2 MG/ML

IV dose of 400mg

Sponsors & Collaborators

  • St. Antonius Hospital

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2021-03-23
Completion
2021-03-23

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT04122560 on ClinicalTrials.gov