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A Clinical Study to Evaluate the Bioavailability Between Two Products Containing Paliperidone 100 mg in the Form of a Prolonged Release Suspension for Injection in Patients With Schizophrenia Who Are Already Stabilized in This Treatment

NCT03425552 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-07-19

No results posted yet for this study

Summary

This clinical study will compare the equivalence of two products containing Paliperidone 100 mg in the form of a prolonged release suspension for injection in patients affected by schizophrenia who are already receiving this treatment. Each patient will receive both products (Test and Reference). In total, each patient will receive 10 doses (five doses of the Test product and five doses of the Reference product; one dose every 28 days). Furthermore, the two products (Test and Reference) will be compared with regard to their safety and tolerability.

Conditions

Interventions

DRUG

Paliperidone

Paliperidone Palmitate extended-release injectable suspension 156 mg (100 mg of Paliperidone)

DRUG

Paliperidone

Paliperidone Palmitate 156 mg (equivalent to Paliperiodne 100 mg) extended release injectable suspension

Sponsors & Collaborators

  • Pharmathen S.A.

    lead INDUSTRY

Principal Investigators

  • Lina Sabbah · Triumpharma

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-11
Primary Completion
2019-05-02
Completion
2019-05-02

Countries

  • Jordan

Study Locations

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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 NCT03425552 on ClinicalTrials.gov