Comparative Bioavailability of Risperidone
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|ClinicalTrials.gov Identifier: NCT03527186|
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : July 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Risperidone ISM® 100 mg||Phase 1|
This is an open-label, 1-sequence study in subjects who are on stable oral risperidone treatment. The study consists of a screening visit, 1 treatment period with inpatient and outpatient visits, and a follow-up visit.
Subjects who are on existing oral risperidone treatment (4 mg) will continue the oral regimen for 1 week to achieve steady-state concentrations of risperidone. Following the oral risperidone treatment, a single intramuscular (IM) dose of 100 mg risperidone ISM® will be administered deeply into the gluteal muscle. A total of 4 IM doses will be given that will be separated by 4 weeks.
Safety assessments and pharmacokinetic (PK) sampling will be performed on each dosing day and each outpatient visit. A final follow-up visit will take place to assess each subject for safety and to obtain PK samples.
Approximately 58 subjects will be enrolled, with the intent to complete 41 subjects. Fifty-eight subjects were estimated for enrollment based on 41 completers assuming an approximate drop-out rate of 30%.
The primary objective of this study is to evaluate the steady-state comparative bioavailability of 100 mg risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.
The secondary objective of this study is to evaluate the safety and tolerability of 100 mg risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||This is an open-label, 1-sequence study to evaluate the PK, safety, and tolerability of risperidone ISM® in subjects with schizophrenia who are on stable oral risperidone treatment. The study consists of a screening visit, 1 treatment period with inpatient and outpatient visits, and a follow-up visit.|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Intramuscular Risperidone ISM® and Oral Risperidone|
|Actual Study Start Date :||July 9, 2018|
|Actual Primary Completion Date :||March 23, 2019|
|Actual Study Completion Date :||April 6, 2019|
Experimental: Risperidone ISM 100 mg
A single intramuscular (IM) dose of 100 mg risperidone ISM® will be administered deeply into the gluteal muscle. A total of 4 IM doses will be given; each dose will be separated by 4 weeks
Drug: Risperidone ISM® 100 mg
100 mg of risperidone ISM® administered every 4 weeks
Other Name: DORIA
- Area under the curve during the dosing interval (AUCtau) [ Time Frame: 28-day period following administration of the fourth dose of risperidone ISM® ]mean steady-state area under the curve during the dosing interval for the active moiety
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): NCT03527186
|United States, California|
|Collaborative Neuroscience Network|
|Long Beach, California, United States, 90806|
|United States, New Jersey|
|Hassman Research Institute|
|Berlin, New Jersey, United States, 08009|
|Study Chair:||Jordi Llaudó, MD||Laboratorios Farmacéuticos Rovi|