Bioavailability Mechanistic Study of Hot-Melt Extruded Amorphous Solid Dispersions

Completed 16 enrolled University Hospital, Basel, Switzerland University of Basel · collab

RandomizedCrossoverOpen-labelBasic science

Summary

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.

Timeline

Start: 2019-04-30
Primary completion: 2020-03-19
Completion: 2020-03-19

Publications

Results Schittny A, Waldner S, Duthaler U, Vorobyev A, Abramovich R, Krahenbuhl S, Puchkov M, Huwyler J. Particle Forming Amorphous Solid Dispersions: A Mechanistic Randomized Pharmacokinetic Study in Humans. Pharmaceutics. 2021 Mar 17;13(3):401. doi: 10.3390/pharmaceutics13030401.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efavirenz	Other / unclassified	3 mg	Oral
Subject	Efavirenz	Other / unclassified	50 mg	Oral

Indications

No indication recorded.