Gastrointestinal behavior of posaconazol in healthy human volunteers
Phase 1
- Conditions
- Suspension: 105 mg posaconazol (2.6 ml Noxafil): 1)with 250 ml water 2)with 250 ml sparkling water 3)with 5 lumps of sugar, dissolved in 250 ml water 3)with 5 lumps of sugar, dissolved in 250 ml of sparkling water. Solution: 105 mg dissolved posaconazol (via Noxafil) by acidification of HCl until pH 1.2: 1)with 250 ml water 2)with 250 ml sparkling water 3)with 5 lumps of sugar, dissolved in 250 ml water 3)with 5 lumps of sugar, dissolved in 250 ml of sparkling water.Therapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2013-002836-26-BE
- Lead Sponsor
- KU Leuven - Drug Delivery & Disposition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
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 10
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 volunteers by using a suspension of the drug and a solution. This will learn us more about the behaviour of the drug in the GI tract (supersaturation/ precipitation/ dissolution/ ...);<br> Secondary Objective: 1)To see any difference between administration of a suspension of the drug versus a solution (differences to supersaturation potential, precipitation potential and absorption potential)<br> 2)To see any difference of supersaturation, precipitation or absorption between the 2 formulations, when there is another time of gastric emptying (induced by the lumps of sugar/ sparkling water)<br> ;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