Gastrointestinal behavior of posaconazol in healthy human volunteers

Gastrointestinal behavior of posaconazol in healthy human volunteers - Gastrointestinal behavior of posaconazol in healthy human volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002836-26-BE

Enrollment

Registered

2013-11-25

Start date

2014-01-09

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Posaconazol 40mg/mL Suspension Product Name: Noxafil Pharmaceutical Form: Suspension for use in drinking water

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 10 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 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/ ...); 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) 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) ;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

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/ ...); 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) 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) ;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

bart.hens@pharm.kuleuven.be3216330302

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026