To allow marketing of a new generic risperidone tablet by regulatory authorities, the present study was designed to compare the bioequivalence
of the test formulation and a reference formulation in healthy Chinese male volunteers. 2 Subjects and Methods This study was conducted at the Phase I Clinical Center of Shanghai Xuhui Central Hospital (Shanghai, China). The study was performed in accordance with the ethical principles for studies in humans described in the Declaration of Helsinki and its amendments , the International Conference on Harmonisation Guideline for Good Clinical Practice , and the Guideline for Good Clinical Principles recommended by the State Food and Drug Administration (SFDA) of China . The study protocol and the informed
consent form were approved by the independent ethics committee of Shanghai Xuhui Central Hospital. selleck products 2.1 Subjects Healthy male Chinese volunteers aged between 18 and 40 years and with a body mass index of 19–24 kg/m2 were enrolled in the study. Eligibility for enrollment was determined by documentation of the complete medical history, a physical examination, monitoring of vital signs (SB273005 concentration including the resting blood pressure, heart rate, oral body temperature, and respiratory rate), a 12-lead electrocardiogram, and laboratory analyses (measuring the
complete BKM120 cell line blood count, total bilirubin, direct bilirubin, serum creatinine, fasting blood glucose, blood urea nitrogen, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, serum albumin, Montelukast Sodium sodium, potassium, calcium, hepatitis B surface antigen, hepatitis C antibody, and HIV antibodies). Subjects were excluded from enrollment if they were active smokers, had a history of alcohol or drug abuse, and/or had any clinically significant abnormality, on the basis of their medical history, physical examination, and laboratory analyses. The subjects were instructed to abstain from using any medications for at least 14 days prior to and during the study. The subjects were informed about the details of the study, including the risks and benefits, and provided written informed consent before study participation. They were free to withdraw from the study at any time. 2.2 Study Design and Blood Sampling This study was a single-dose, open-label, randomized-sequence, 2 × 2 crossover bioequivalence study. The two periods were separated by a 2-week washout period based on the known t½ values of risperidone (≤20 hours) and 9-hydroxy-risperidone (≤30 hours). The subjects were assigned to one of two sequence groups, using a random number table generated by SAS® version 9.1.