Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.

NCT00645502 | Completed Phase 1

• 1 other identifier: CR002617
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Schizoaffective Disorders

Keywords

Schizophrenia; Risperidone; Orally-disintegrating tablet; Bioequivalence

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

risperidone DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Start: June 1, 2003
• Study Completion: July 1, 2003
• Last Updated: April 26, 2010

Record last verified: 2010-04