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 | Completed Phase 1

• 1 other identifier: PAL.100/316
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief 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

Schizophrenia

Outcome Measures

Primary Outcomes (3)

• Cmax(ss)

  Maximum plasma concentration at steady state

  28 days

• AUC0-τ(ss)

  AUC during a dosage interval at steady state

  28 days

• Cτ(ss)

  Concentration at the end of the dosing interval at steady state

  28 days

Secondary Outcomes (4)

• Cmin(ss)

  28 days

• Fluctuation

  28 days

• Tmax(ss)

  28 days

• Number of participants with treatment-related adverse events

  281 days

Study Arms (2)

Test treatment

EXPERIMENTAL

Paliperidone palmitate extended-release injectable suspension for intramuscular use 156 mg (100 mg of Paliperiodne)

Drug: Paliperidone

Reference treatment

ACTIVE COMPARATOR

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

Drug: Paliperidone

Interventions

Paliperidone DRUG

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

Test treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is suffering from Schizophrenia.
• The patient age is \> 18 years and \< 65 years old (inclusive).
• The patient has a body weight not less than 50 Kg and according to the BMI range (18.5 - 35 Kg/m2), (inclusive)
• The patient has received at least 3 doses of Paliperidone 100 mg Prolonged Release Suspension for Injection within the last 3 months.
• The patient is under fasting conditions (food and drinks) for at least 8 hours on the day of screening.
• The patient is available to volunteer for the entire study duration and is willing to adhere to all protocol requirements.
• The findings of the patient are within the range of clinical acceptability in medical history, physical examination, vital signs, ECG, and laboratory results.
• The legally acceptable representative signed the informed consent form and the patient is able to communicate with the investigator and comprehend study-related procedures.
• The patient agrees to use a condom if he is engaged in sexual activity with a woman of childbearing potential.
• A condom is required along with another medically acceptable contraceptive method. Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide).
• Female patients may be included but must comply with the following in order to be included:
• Women having the potential to become pregnant can be enrolled only if willing to use a clinically acceptable (i.e. intrauterine device or hormonal contraceptives for at least three months) or a double barrier contraceptive measure (i.e. condom and spermicidal gel or diaphragm and spermicidal gel for at least 14 days) prior to the start of the study and through the study and for 30 days after completion of the study, or
• Surgically sterilized for at least 6 months or
• Menopausal women, for at least 1 year

You may not qualify if:

• The patient is pregnant or nursing (lactating) women, where pregnancy is defined as the state of the female after conception and until the termination of gestation, confirmed by a positive urine or serum pregnancy test.
• The patient has any significant or organ abnormality as determined by the principal investigator/sub-investigator.
• The patient has skin abnormalities/irritations at the potential injection site (right or left deltoid) as determined by the Principal Investigator/clinical Sub-Investigator.
• The patient has a medical or surgical condition that might interfere with the absorption, metabolism, or excretion of paliperidone.
• The patient has known allergy to the Paliperidone Palmitate or to any ingredient in the preparation.
• The patient has a history of hypersensitivity to heparin.
• The patient intended to significantly change the smoking habits during the trial (i.e. planned cessation or start of smoking career).
• The patient will consume alcohol or caffeine or related xanthine containing foods or beverages for 48 hours prior to each dosing.
• The patient will consume grapefruit or pomelo-containing beverages and foods within 7 days prior to each dosing.
• The patient has a history of or current compulsive abuse of alcohol (more than 10 drinks weekly) or regular exposure to other substance of abuse.
• The patient is on a special diet (for example the patient is a vegetarian), or dieting (on a weight lowering plan) during the month before the study.
• The patient participated in a comparative bioavailability/ bioequivalence study within the last 90 days before first dose of period I.
• The patient participated in a clinical study within the last 90 days before first dose of period I.
• The patient donated blood or any of its constituents (1 unit or 350 ml) within the last 90 days before first dose of period I.
• The patient has positive testing for HIV I \& II and/or Hepatitis B and/or Hepatitis C using ELISA method.

Sponsors & Collaborators

• Pharmathen S.A.: lead

Study Sites (3)

Al-Esraa Hospital

Amman, Jordan

Location

King Abdullah University Hospital

Ar Ramtha, Jordan

Location

Princes Basma Teaching Hospital

Irbid, Jordan

Location

Related Links

• Guideline for Good Clinical Practice E6(R2)

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Lina Sabbah

  Triumpharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 7, 2018
• Study Start: March 11, 2018
• Primary Completion: May 2, 2019
• Study Completion: May 2, 2019
• Last Updated: July 19, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

JO (3)