Bioavailability Mechanistic Study of Hot-Melt Extruded Amorphous Solid Dispersions (BEAD)

NCT03886766 NA COMPLETED

It is the aim of the study to investigate the functioning of a drug delivery system (drug-rich particles forming hot-melt extruded amorphous solid dispersions) with respect to mechanisms of bioavailability of poorly soluble drug substances.

Details

Lead sponsor	University Hospital, Basel, Switzerland
Phase	NA
Status	COMPLETED
Enrolment	16
Start date	Tue Apr 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Mar 19 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Biological Availability
• Amorphous Solid Dispersions

Interventions

• Hot-melt extruded amorphous solid dispersion of Efavirenz
• Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles
• Efavirenz solution

Countries

Switzerland