deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT03425552

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.

Conditions Schizophrenia
Interventions Paliperidone
Updated 9 times since 2018 Last updated: Jul 18, 2019 Started: Mar 11, 2018 Primary completion: May 2, 2019 Completion: May 2, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshotNot Yet Recruiting~Apr 2018 – ~May 2018 · 30 days · monthly snapshotRecruiting~May 2018 – ~Jun 2018 · 31 days · monthly snapshotRecruiting~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshotRecruiting~Nov 2018 – ~Aug 2019 · 9 months · monthly snapshotActive Not Recruiting~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 24 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Aug 2019 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not RecruitingCompleted

  5. Nov 2018 — Aug 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: RecruitingActive Not Recruiting

Show 4 earlier versions
  1. Jun 2018 — Nov 2018 [monthly]

    Recruiting PHASE1_PHASE2

  2. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  3. Apr 2018 — May 2018 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet RecruitingRecruiting

  4. Mar 2018 — Apr 2018 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pharmathen S.A.
Data source: Pharmathen S.A.

For direct contact, visit the study record on ClinicalTrials.gov .