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An Open-Label, Long-Term, Multiple-Dose, Safety and Tolerability, Pharmacokinetic Study of 150 mg eq. Paliperidone Palmitate in the Treatment of Subjects With Schizophrenia
The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to document the pharmacokinetics of paliperidone following fixed multiple intramuscular injections of paliperidone palmitate 150 mg eq.
Details
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 212 |
| Start date | 2007-09 |
| Completion | 2009-06 |
Conditions
- Schizophrenia
Interventions
- Paliperidone palmitate Treatment A
- Paliperidone palmitate Treatment B
Primary outcomes
- The number of patients experiencing treatment emergent adverse events — Screening (Day -21 to -1) to Day 372 (or at the time of early termination from the study)
- Concentration of paliperidone in plasma from blood samples obtained from patients — Day 1 to Day 372
Countries
United States, Belgium, Croatia, Malaysia, Poland, Slovakia, South Korea, Spain, Taiwan, Thailand