Exposure to fluconazole in obese patients.

Fluconazole pharmacokinetics, including bioavailability, in Obese subjects after an Intravenous and oral Administration (FOLIA). - DONUT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002613-35-NL

Enrollment

Registered

2018-07-23

Start date

2018-11-05

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics of fluconazole in obese subjects. MedDRA version: 20.0 Level: PT Classification code 10017533 Term: Fungal infection System Organ Class: 10021881 - Infections and infestations

Interventions

Pharmaceutical Form: Solution for infusion INN or Proposed INN: Fluconazole CAS Number: 86386-73-4 Other descriptive name: FLUCONAZOLE Concentration unit: mg/ml milligram(s)/millilitre Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects BMI: a. obese groups: subject must have a BMI =35 kg/m2 at the time of inclusion or has undergone bariatric surgery; b. non-obese group: subject must have a BMI =18.5 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Documented history of sensitivity to medicinal products or excipients similar to those found in the fluconazole preparation; 2. History of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration); 3. Use of medication that has known relevant interaction with study drug as determined by the investigator up to 1 weeks prior to study drug administration; 4. Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks prior to study drug administration; 5. Blood transfusion within 8 weeks prior to study drug administration; 6. Treatment with the concerning study drug up to 7 days before administration of the study drug; 7. Any other sound medical, psychiatric and/or social reason as determined by the investigator.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effect of obesity (BMI =35 kg/m2) and bariatric surgery on the pharmacokinetics, including oral bioavailability of fluconazole.;Secondary Objective: To develop a dosing regimen for obese patients.;Primary end point(s): Determine PK parameters (Bioavailability, Systemic Clearance, Volume of distribution of central compartment, Volume of distribution of peripheral compartment(s), Intercompartmental Glearance) after a single oral and intravenous dose.;Timepoint(s) of evaluation of this end point: Day 1, 2 and 3	—

Measure

Time frame

Main Objective: To determine the effect of obesity (BMI =35 kg/m2) and bariatric surgery on the pharmacokinetics, including oral bioavailability of fluconazole.;Secondary Objective: To develop a dosing regimen for obese patients.;Primary end point(s): Determine PK parameters (Bioavailability, Systemic Clearance, Volume of distribution of central compartment, Volume of distribution of peripheral compartment(s), Intercompartmental Glearance) after a single oral and intravenous dose.;Timepoint(s) of evaluation of this end point: Day 1, 2 and 3

—

Secondary

Measure	Time frame
Secondary end point(s): Simulate PK to predict long-term exposure (after repeated dosing);Timepoint(s) of evaluation of this end point: Day 1, 2 and 3	—

Countries

Netherlands

Contacts

Public ContactRoger Brüggemann

Radboud university medical center

roger.bruggemann@radboudumc.nl+31243616405

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026