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Bioavailability Mechanistic Study of Hot-Melt Extruded Amorphous Solid Dispersions

NCT03886766 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-12-20

No results posted yet for this study

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.

Conditions

  • Biological Availability
  • Amorphous Solid Dispersions

Interventions

DRUG

Hot-melt extruded amorphous solid dispersion of Efavirenz

Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1)

DRUG

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

Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2)

DRUG

Efavirenz solution

Efavirenz solution, 3 mg, oral administration (product 3)

Sponsors & Collaborators

  • University of Basel

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Stephan Krähenbühl, Prof. Dr. · University of Basel, Department Biomedicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03886766 on ClinicalTrials.gov