Status:
COMPLETED
Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Schizoaffective Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00645502
Start Date
June 1 2003
End Date
July 1 2003
Last Update
April 26 2010
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