Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.

Study Description

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Brief Summary:

The primary objective of this study is to demonstrate the bioequivalence, with respect to risperidone and its active moiety, of a single oral dose of risperidone given as a 4 mg orally-disintegrating tablet and as a 4 mg conventional RISPERDAL tablet. In addition, their tolerability and safety will be documented.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorders	Drug: risperidone	Phase 1

Detailed Description:

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 concentrations of the drug will be measured. Serial blood collections will be made beginning at 0 hour (immediately before study drug administration) and continuing up to 96 hours after study drug administration in each period. Safety will be evaluated throughout the study using physical examinations, electrocardiogram recordings (ECG), clinical laboratory testing (hematology, serum chemistry, urinalysis), vital signs measurements, pregnancy testing, drug screening, and monitoring of adverse events. The study will be approximately 6 weeks long (including the screening period). Subjects will enter the study facility 3 days before the first administration of study medication on Day 1 of the first period. They will remain at the facility until all study-related procedures are completed on Day 5 of the second study period, a period of approximately 18 days. 4 mg risperidone (either conventional tablet or orally-disintegrating tablet), single dose, oral intake

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Bioequivalence Study Comparing a Single Oral Intake of a 4mg Orally-disintegrating Tablet With a 4mg Conventional Risperdal Tablet in Patients With Schizophrenia
Study Start Date :	June 2003
Actual Study Completion Date :	July 2003

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. PK parameters (Cmax and AUC) for active moiety, 9-OH-risperidone and risperidone

Secondary Outcome Measures :

1. Safety assessments including adverse events, physical examination, vital signs, ECGs and labs

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:	Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

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ClinicalTrials.gov Identifier:	NCT00645502 History of Changes
Other Study ID Numbers:	CR002617
First Posted:	March 27, 2008
Last Update Posted:	April 26, 2010
Last Verified:	April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Schizophrenia; Risperidone; Orally-disintegrating tablet; Bioequivalence

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Risperidone; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents	Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents