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
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
Sponsor: Pharmathen S.A.
Listed as NCT03425552, this PHASE1/PHASE2 trial focuses on Schizophrenia and remains completed. Sponsored by Pharmathen S.A., it has been updated 9 times since 2018, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.
Status Flow
Change History
9 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
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Aug 2019 — Jan 2021 [monthly]
Completed PHASE1_PHASE2
Status: Active Not Recruiting → Completed
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Nov 2018 — Aug 2019 [monthly]
Active Not Recruiting PHASE1_PHASE2
Status: Recruiting → Active Not Recruiting
▶ Show 4 earlier versions
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Jun 2018 — Nov 2018 [monthly]
Recruiting PHASE1_PHASE2
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May 2018 — Jun 2018 [monthly]
Recruiting PHASE1_PHASE2
-
Apr 2018 — May 2018 [monthly]
Recruiting PHASE1_PHASE2
Status: Not Yet Recruiting → Recruiting
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Mar 2018 — Apr 2018 [monthly]
Not Yet Recruiting PHASE1_PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Pharmathen S.A.
For direct contact, visit the study record on ClinicalTrials.gov .