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

Study information

Recruitment status

Completed

Enrollment listed in the registry

70

Sponsor

Pharmathen S.A.

Sponsor type

Unknown or unclear

Study type

Drug

Intervention type

Medication / drug

Study phase

Phase 1, Phase 2iThis study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.

Locations

Jordan

Age range

From 18 Years to 65 Years

Official registry ID

NCT03425552

Official title

Show the full 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