A Study of Paliperidone Blood Concentrations in Patients With Schizophrenia After Administration of Paliperidone Palmitate
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|ClinicalTrials.gov Identifier: NCT01110317|
Recruitment Status : Completed
First Posted : April 26, 2010
Last Update Posted : April 27, 2010
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: paliperidone palmitate 100 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Parallel, Randomized, Multiple-Dose Pharmacokinetic Study of Paliperidone After Intramuscular Injection of Paliperidone Palmitate in the Deltoid or Gluteal Muscle in Subjects With Schizophrenia|
|Study Start Date :||July 2005|
|Actual Study Completion Date :||March 2006|
paliperidone palmitate 100 mg Patients will receive a single paliperidone palmitate 100 mg equivalent injection in the gluteal or deltoid muscle on Day 1 8 36 and 64.
Drug: paliperidone palmitate 100 mg
Patients will receive a single paliperidone palmitate 100 mg equivalent injection in the gluteal or deltoid muscle on Day 1, 8, 36, and 64.
- Determination of the concentration of paliperidone in blood samples obtained from patients. [ Time Frame: Predose at specified time points (Days 18, 20, 22, 29, 46, 50, 85, 92, 99, 106, 120, 134, 148, 162, and 176) during the study through Day 176 or the time of early withdrawal from the study. ]
- The safety of paliperidone palmitate i.m. injections in patients will be evaluated by injection site evaluations, clinical laboratory tests, vital signs measurements, and physical examinations. [ Time Frame: From time of screening (Visit 1) through the end of study (Visit 33 [Day 176]) or at the time of early withdrawal from the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110317
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|