Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.
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ClinicalTrials.gov Identifier: NCT00645502 |
Recruitment Status
:
Completed
First Posted
: March 27, 2008
Last Update Posted
: April 26, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia Schizoaffective Disorders | Drug: risperidone | Phase 1 |
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 |

- PK parameters (Cmax and AUC) for active moiety, 9-OH-risperidone and risperidone
- Safety assessments including adverse events, physical examination, vital signs, ECGs and labs

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645502
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00645502 History of Changes |
Other Study ID Numbers: |
CR002617 |
First Posted: | March 27, 2008 Key Record Dates |
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 |