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Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.

Primary Purpose

Schizophrenia, Schizoaffective Disorders

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

risperidone

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Orally-disintegrating tablet, Bioequivalence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00645502

First Posted

March 24, 2008

Last Updated

April 22, 2010

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00645502

Brief Title

Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.

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 Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorders

Keywords

Schizophrenia, Risperidone, Orally-disintegrating tablet, Bioequivalence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

risperidone

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.

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