Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.

Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Mar 26, 2008

Keywords

ClinConnect Summary

This is a single-center, open, randomized, 2-way crossover bioequivalence study in 40 subjects with schizophrenia or schizoaffective disorder. The study will consist of 2 treatment periods, 5 days per period. The subjects will receive a single 4 mg RISPERDAL conventional tablet in period 1 and a single 4 mg orally-disintegrating tablet in period 2; or the orally disintegrating tablet in period 1 and conventional tablet in period 2. A washout period of at least 10 days between Day 1 of Period 1 and Day 1 of Period 2 will separate the 2 treatments. In both treatment periods plasma concentrati...

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Eligibility criteria

• Inclusion Criteria:
• • Patients with diagnosis of schizophrenia of any subtype
• • who have a normal weight as defined by Body Mass Index in range of 18.0 to 35.0, extremes included
• • For whom an Informed consent form signed by the patient or legally acceptable representative is available and who are healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram (ECG), and the results of blood biochemistry and hematology tests and a urinalysis carried out less than 3 weeks before the first dose of study medication is taken
• Exclusion Criteria:
• • Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV
• • Patients who received oral risperidone or paliperidone within 14 days of first drug administration, Risperdal Consta within 100 days of first drug administration or paliperidone palmitate within 10 months of first drug administration
• • Patients who used medication known to be an hepatic enzyme inducer or inhibitor less than 2 weeks prior to first drug administration
• • Patients with history of allergic reaction to risperidone or its excipients
• • Patients with diagnosis of alcohol or substance abuse
• • Patients with history of clinically relevant cardiac arrhythmia's, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, parkinsonism, or drug allergy
• • Female patients who are pregnant or are breastfeeding or are of childbearing potential without adequate contraception.