NCT04122560

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The pharmacokinetics of fluconazole are expected to be different in obese patients compared to non-obese patients. Therefore, extrapolation of data from healthy volunteers and is not possible. To investigate these differences 16 obese patients and 8 healthy subjects will be studied. Patients will receive fluconazole by semi-simultaneous design. Blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter. A maximum of 100 milliliter blood in total will be drawn for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug. Full pharmacokinetic curves will be taken after oral and intravenous administration. This pharmacokinetic analysis will enable the determination of bioavailability and enable the determination of intra-individual variability.

Conditions

• Fluconazole
• Candidiasis
• Invasive Fungal Infections
• Obesity

Interventions

Type	Name	Description
DRUG	Fluconazole 200mg tab	PO dose of 400mg
DRUG	Fluconazole 2 MG/ML	IV dose of 400mg

Timeline

• Start date: 2019-11-30
• Primary completion: 2021-03-23
• Completion: 2021-03-23
• First posted: 2019-10-10
• Last updated: 2021-07-14

Locations

2 sites across 1 country: Netherlands