A Bioequivalence Study of 15 mg ER OROS Paliperidone

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.