A Phase 1 interventional study of ER OROS Paliperidone in Schizophrenia, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-08.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the bioequivalence between the Phase 3 and the to-be-marketed formulations of extended release (ER) OROS paliperidone and to evaluate the effect of food on the highest to be marketed tablet strength. Additionally, the safety and tolerability of the treatments in healthy volunteers will be assessed.
This study is designed as a single-center, open-label, randomized, 3 treatment-period, crossover study in healthy male adults. The study consists of a screening phase and an open-label treatment phase during which each volunteer will receive 3 treatments of study drug in a random order and separated by a washout period of 10 to 14 days. Treatment A consists of a single oral dose of 15 mg ER OROS paliperidone Phase 3 formulation in the fasted state; Treatment B consists of a single oral dose of 15 mg ER OROS paliperidone to-be-marketed formulation in fasted state; and Treatment C consists of a single oral dose of 15 mg ER OROS paliperidone to-be-marketed formulation after consumption of a high-fat breakfast. There are slight formulation differences between the ER OROS paliperidone formulation that was used in Phase 3 efficacy studies and the formulation that is intended to be marketed. What is more important, however, is that the highest tablet strength used in Phase 3 and the tablet strength that is planned for the market as commercial formulation are different. For Phase 3 studies, 9 mg was the highest tablet strength and the highest dose of 15 mg was administered as 2 tablets of 3 mg and 1 tablet of 9 mg. The highest to-be-marketed tablet strength is 15 mg. This study is designed to demonstrate the bioequivalence between the Phase 3 formulation and the highest tablet strength of the to-be-marketed formulation and to assess the effect of food on the highest to-be-marketed tablet strength. Safety and tolerability will be monitored throughout the study. All volunteers will receive each of the following 3 treatments in the order specified by the random assignment:Treatment A, oral ER OROS paliperidone Phase 3 formulation as 2 tablets of 3 mg and 1 tablet of 9 mg in the fasted state; Treatment B, oral ER OROS paliperidone to-be-marketed formulation as 1 tablet of 15 mg in the fasted state; Treatment C, oral ER OROS paliperidone to-be-marketed formulation as 1 tablet of 15 mg after a high-fat breakfast.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
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Exclusion Criteria:
To evaluate the bioequivalence between the Phase 3 and the to-be-marketed formulations of ER OROS paliperidone and to evaluate the effect of food on the highest to-be-marketed tablet strength
To evaluate the safety and tolerability of the treatments in healthy volunteers
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This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.