Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorders
Intervention: risperidone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: PK parameters (Cmax and AUC) for active moiety, 9-OH-risperidone and risperidone
Secondary outcome: Safety assessments including adverse events, physical examination, vital signs, ECGs and labs
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: June 2003
Last updated: April 22, 2010
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