Status:
COMPLETED
Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
St. Antonius Hospital
Conditions:
Fluconazole
Candidiasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 1...
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 inv...
Eligibility Criteria
Inclusion
- Subjects BMI:
- obese groups: subject must have a BMI ≥35 kg/m2 at the time of inclusion or has undergone bariatric surgery;
- non-obese group: subject must have a BMI ≥18.5 and \<30 kg/m2 at the time of inclusion;
- Subject is at least 18 of age on the day of screening and not older than 65 years of age on the day of dosing;
- Subject able and willing to sign the Informed Consent before screening evaluations.
- If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
- For the non-obese subjects the following additional inclusion criteria applies:
- Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry and hematology within 6 weeks prior to study drug administration. Results of biochemistry and hematology should be within the laboratory's reference ranges (see Appendix A). If laboratory results are not within the reference ranges, the subject is included based on the investigator's judgment that the observed deviations are not clinically relevant. This should be clearly recorded.
Exclusion
- Documented history of sensitivity to fluconazole or similar azole-compound;
- Documented history of the long QT syndrome (LQTS);
- History of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration);
- 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;
- 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;
- Blood transfusion within 8 weeks prior to study drug administration;
- Treatment with the concerning study drug up to 7 days before administration of the study drug;
- Any other sound medical, psychiatric and/or social reason as determined by the investigator.
Key Trial Info
Start Date :
November 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04122560
Start Date
November 30 2019
End Date
March 23 2021
Last Update
July 14 2021
Active Locations (2)
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1
St. Antonius hospital
Nieuwegein, Netherlands
2
Radboudumc
Nijmegen, Netherlands