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

NCT04411953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-06-08

Study results available
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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.

Conditions

  • Bioequivalence

Interventions

DRUG

Haloperidol Tablets, Mylan Pharmaceuticals Inc.

single dose, 2 mg Haloperidol tablet

DRUG

Haloperidol Tablets, Cycle Pharmaceuticals Ltd

single dose, 2 mg Haloperidol tablet

Sponsors & Collaborators

  • Farmovs

    collaborator INDUSTRY

  • Cycle Pharmaceuticals Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2019-12-19
Completion
2019-12-19

Countries

  • South Africa

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 NCT04411953 on ClinicalTrials.gov