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A Bioequivalence Study of APX001 High-load and Low-load Tablets

NCT05491733 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-07-11

No results posted yet for this study

Summary

A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.

Conditions

  • Invasive Fungal Infections

Interventions

DRUG

APX001

Low-load oral tablet

DRUG

APX001A

High-load oral tablet

Sponsors & Collaborators

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Marc Engelhardt · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2021-05-13
Completion
2021-06-23
FDA Drug
Yes

Countries

  • United States

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 NCT05491733 on ClinicalTrials.gov