Exploring how the tablet Noxafil reacts in the human body after oral intake
Phase 1
- Conditions
- •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)Therapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2015-002703-28-BE
- Lead Sponsor
- KU Leuven - Drug Delivery & Disposition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
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
-pregnancy
-disease
-use of medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Study of the gastrointestinal behavior of posaconazol in healthy<br>volunteers by using Noxafil tablet. This will learn us more about the behaviour of the drug in the GI tract (supersaturation/ precipitation/ dissolution/ ...)<br>;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 Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable