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

Radboud university medical centre0 个研究点目标入组 24 人开始时间: 2018年7月23日最近更新: 2021年3月30日

适应症

试验速览

暂无简介。

•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 <30 kg/m2 at the time of inclusion;
•2.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;
•3.Subject able and willing to sign the Informed Consent before screening evaluations.
•For the non-obese subjects the following additional inclusion criteria applies:
•4.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.
•5.If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.

发起方

Radboud university medical centre