• Administering one tablet of Noxafil with a glass of 240 ml of water • Administering four tablets of Noxafil with a glass of 240 ml of water • Administering one tablet of Noxafil with a glass of 240 ml of water, prior to the intake of 400 ml Ensure plus (liquid meal) • Administering four tablets of Noxafil with a glass of 240 ml of water, prior to the intake of 400 ml Ensure plus (liquid meal)
Conditions
Interventions
Trade Name: Noxafil Tablet 100 mg
Product Name: Noxafil
Pharmaceutical Form: Tablet
Sponsors
KU Leuven - Drug Delivery & Disposition
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Healthy volunteers -age between 18 and 40 years old 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 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -pregnancy -disease -use of medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study of the gastrointestinal behavior of posaconazol in healthy volunteers by using Noxafil tablet. This will learn us more about the behaviour of the drug in the GI tract (supersaturation/ precipitation/ dissolution/ ...) ;Secondary Objective: To see if there is any difference in disposition of the tablet in fasting or postprandial conditions;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium
Contacts
Public ContactDrug Delivery & Disposition
KU Leuven
Outcome results
None listed