Completed PHASE1 INTERVENTIONAL 2-arm NCT04411940

Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions

A Single Center, Single Dose, Open-label, Randomized, Two Period Crossover Pivotal Study to Determine the Bioequivalence of Two Formulations Containing Haloperidol 2 mg in Healthy Males and Females Under Fasting Conditions

Sponsor: Cycle Pharmaceuticals Ltd.

Conditions Bioequivalence

Interventions Haloperidol Tablets, Cycle Pharmaceuticals Ltd Haloperidol Tablets, Mylan Pharmaceuticals Inc.

Updated 6 times since 2020 Last updated: Mar 9, 2022 Started: Nov 15, 2019 Primary completion: Dec 18, 2019 Completion: Dec 18, 2019

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

Listed as NCT04411940, this PHASE1 trial focuses on Bioequivalence and remains completed. Sponsored by Cycle Pharmaceuticals Ltd., it has been updated 6 times since 2019, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Mar 2025 — Present [monthly]

Completed PHASE1
Sep 2024 — Mar 2025 [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jul 2022 — Jul 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2022 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jul 2020 — Jan 2021 [monthly]

Completed PHASE1

First recorded

Nov 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Cycle Pharmaceuticals Ltd.
Farmovs

Data source: Cycle Pharmaceuticals Ltd.

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

Study Locations

• Bloemfontein, South Africa