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

Schizophrenia Clinical Trial

Official title: Α Randomized, Two-way, Two-treatment, Two-period, Crossover, Open Label, Laboratory-blind, Comparative Bioavailability Study at Steady State Between Paliperidone 100 mg Prolonged Release Suspension for Injection (Test Product) and Xeplion® 100 mg Prolonged Release Suspension for Injection (Reference Product) Following Multiple Intramuscular Injections (Five Doses in Each Period, One Dose Every 28 Days) Administration to Patients With Schizophrenia Who Are Already Receiving a Stable Regimen of Paliperidone Prolonged Release Suspension Via The Intramuscular Route

Status Completed

Clinical Trial 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.

Clinical Trial Description

This study will be a randomized, two-way, two-treatment, two-period, crossover, open label, laboratory-blind, multiple dose study at steady state, under fasting conditions.

To main purpose of this study is to determine the relative bioavailability of Paliperidone 100 mg prolonged release suspension for injection (Pharmathen S.A, Greece) and Xeplion® (Paliperidone) 100 mg Prolonged Release Suspension for Injection (Janssen Pharmaceutica N.V., Belgium) following multiple Intramuscular Injections (five doses in each period, one dose every 28 days) administration to patients with schizophrenia who are already receiving a stable regimen of paliperidone prolonged release suspension via the intramuscular route.

The secondary objective of this study is to evaluate the safety and tolerability between the two products.

Five injections of Paliperidone 100 mg prolonged release suspension will be administered intramuscularly (in the deltoid muscle) to study patients in each period (one injection every 28 days).

A total of 70 patients will be randomized into two sequences (Test-Reference or Reference-Test).

The doses will be administered to study patients in each period, according to the randomization plan , as clarified in the table below:

Period I Day 0 First dose Day 28 Second dose Day 56 Third dose Day 84 Fourth dose Day 112 Fifth Dose

Period II Day 140 First dose Day 168 Second dose Day 196 Third dose Day 224 Fourth dose Day 252 Fifth Dose

Following up the last dose of each period, a series of blood samples will be collected from each patient in order to determine the bioavailability of the received drug. More specifically, patients will return to the clinical site to give the scheduled PK blood samples on Day 113, Day114, Day 115, Day 116, Day 117, Day 118, Day 119, Day 120, Day 121, Day 122, Day 123, Day 124, Day 125, Day 126, Day 127, Day 128, Day 129, Day 130, Day 132, Day 134, Day 136, Day 138, Day 253, Day 254, Day 255, Day 256, Day 257, Day 258, Day 259, Day 260, Day 261, Day 262, Day 263, Day 264, Day 265, Day 266, Day 267, Day 268, Day 269, Day 270, Day 272, Day 274, Day 276, Day 278 and Day 280. ;

Related Conditions & MeSH terms

• Schizophrenia

• NCT number: NCT03425552
• Study type: Interventional
• Source: Pharmathen S.A.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 11, 2018
• Completion date: May 2, 2019