Completed PHASE1 INTERVENTIONAL 4-arm NCT05026567

Bioavailability Study of Midazolam Administered as a Solution by Conventional Syringe or ZENEO®

A Single Center, Single Dose, Open Label, Randomized, Four-period Crossover Study in Healthy Subjects to Describe and Compare the Plasma Pharmacokinetics of Midazolam After Intramuscular Injection as a Solution by a Conventional Syringe or by the Needle-free Injector ZENEO®

Sponsor: Crossject

Conditions Healthy

Interventions 2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL) ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area ZENEO® Midazolam (10 mg / 0.625 mL) through clothing in thigh ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh

Updated 6 times since 2021 Last updated: Jul 21, 2022 Started: May 9, 2022 Primary completion: Jul 14, 2022 Completion: Jul 15, 2022

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Healthy, this trial is completed. The trial is conducted by Crossject and has accumulated 6 data snapshots since 2022. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Sep 2022 — Jul 2024 [monthly]

Completed PHASE1

Status: Recruiting → Completed
Jun 2022 — Sep 2022 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting
Oct 2021 — Jun 2022 [monthly]

Not Yet Recruiting PHASE1

▶ Show 1 earlier version

Sep 2021 — Oct 2021 [monthly]

Not Yet Recruiting PHASE1

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Crossject

Data source: Crossject

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Bloemfontein, South Africa