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Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs

NCT05857384 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-01-17

No results posted yet for this study

Summary

The goal of this randomised four-period cross-over Phase I study is to assess bioavailability, bioequivalence and tolerability of IHL-42X compared to the reference drugs in healthy volunteers.

Volunteers will be enrolled and randomised to one of four treatment groups. Each group is to receive all four treatments in a twenty eight day cross-over study, with each treatment period running for seven days.

The four treatment groups are described below; A = dronabinol 5 mg, fasted; B = acetazolamide 250 mg, fasted; C = IHL-42X (5 mg dronabinol, 250 mg acetazolamide), fasted; D = IHL-42X (5 mg dronabinol, 250 mg acetazolamide), fed. Each treatment group will enrol at least 29 participants each, for a total of at least 116 participants.

Bioavailability and bioequivalence will assess and compare all four of the seven day treatments.

Conditions

Interventions

DRUG

IHL42X

IHL-42X consists of acetazolamide and dronabinol.

DRUG

Acetazolamide 250 MG

A solid tablet containing 250 mg acetazolamide

DRUG

Dronabinol 2.5 MG

A soft gelatin capsules containing 2.5mg dronabinol

Sponsors & Collaborators

  • Incannex Healthcare Ltd

    lead INDUSTRY

Principal Investigators

  • Emir Redzepagic, MBBS · CMAX Clinical Research

  • Phillip Ryan, MBBS · Nucleus Network Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05857384 on ClinicalTrials.gov