CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Haloperidol Tablets, Mylan Pharmaceuticals Inc. +1 moredrug
Likely dose
Haloperidol Tablets, Mylan Pharmaceuticals Inc. 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04411953
NCT04411953Phase 1Completed
CompareCT.gov

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 Fed Conditions

Cycle Pharmaceuticals Ltd.·interventional·Posted Jun 2, 2020·Updated Jun 8, 2022

In Brief

A Phase 1 clinical trial evaluating Haloperidol Tablets, Mylan Pharmaceuticals Inc. and Haloperidol Tablets, Cycle Pharmaceuticals Ltd for Bioequivalence. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2 mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States Pharmacopeia (USP), 2 mg (Mylan Pharmaceuticals Inc.) are bioequivalent under fed conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioequivalence
CountriesSouth Africa
CollaboratorsFarmovs

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJun 2, 2020
Enrollment StartNov 15, 2019
Primary CompletionDec 19, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.1 years ago

Interventions

Haloperidol Tablets, Mylan Pharmaceuticals Inc.drug

single dose, 2 mg Haloperidol tablet

Haloperidol Tablets, Cycle Pharmaceuticals Ltddrug

single dose, 2 mg Haloperidol tablet