Pharmocokinetic Study of Aripiprazole Extended Release Injectable Suspension in patients with Schizophrenia
- Conditions
- Health Condition 1: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2018/12/016671
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Subjects must fulfill all the following inclusion criteria to be eligible for participation in the study:
1. Male or non-pregnant, non-lactating female subjects between 18 and 65 years of age (inclusive).
2. Documented diagnosis of schizophrenia
3. Subjects who are clinically stable and have had no hospitalization for exacerbation of psychiatric symptoms.
4. Currently stable on a regimen consisting of Aripiprazole Extended-Release Injectable Suspension
5. Subjects with established tolerability to oral Aripiprazole prior to screening
Subjects must not be enrolled in the study if they meet any of the following criteria:
1. Known or suspected allergy or hypersensitivity to aripiprazole or other constituents of the formulation.
2. History of medically significant adverse events or intolerance with aripiprazole based on investigatorâ??s discretion.
3. Subjects who are on active treatment with drugs that are known to interact with Aripiprazole
4. Subjects with history or at risk of venous thromboembolism as per investigatorâ??s discretion.
5. Subjects with poor GFR on screening.
6. Subjects with Clinical Global Impression â?? Severity of illness (CGI-S) score of 5 or more.
7. Subjects with inadequate muscle mass to receive the intramuscular injection according to the investigator.
8. Subjects with a history of Neuroleptic Malignant Syndrome (NMS) or tardive dyskinesia while on treatment with atypical antipsychotics.
9. Subjects with dementia related psychosis.
10. Subjects with history or presence of seizures or other conditions that potentially lower the seizure threshold.
11. Presence of significant orthostatic hypotension
12. Subjects with known cardiovascular disease cerebrovascular disease, uncontrolled Hyperglycemia/diabetes mellitus,.
13. History of drug induced leukopenia/ neutropenia/ agranulocytosis.
14. Subjects with abnormal hematological parameters at screening and randomization
15. Subjects with abnormal liver function tests at screening and randomization
16. History of alcohol or substance abuse during the 6-month period immediately prior to screening.
17. Participation in any interventional clinical study within the past 90 days of randomization.
18. Male or female of childbearing potential unwilling to use adequate methods of contraception throughout the study.
19. History of difficulty with donating blood or difficulty in accessibility of veins.
20. Donation of blood within 90 days prior to receiving the first dose of investigational medicinal product in the study.
21. Subject who had major surgery within 4 weeks prior to study entry, who have not recovered from prior major surgery, or who have surgery scheduled during the course of the study.
22. Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg and/or HCV.
23. Subjects having any other clinically significant finding of the physical examination or laboratory value or any reason which, in the opinion of the investigator, would prevent the subject from safely participating in the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â??Evaluation of bioequivalence of Mylanâ??s Aripiprazole Extended-Release Injectable Suspension 400 mg with Abilify Maintena® (Aripiprazole) 400 mg of Otsuka Pharmaceutical Co., Ltd., Japan, in subjects with schizophrenia.â??Timepoint: 540 Days
- Secondary Outcome Measures
Name Time Method Safety assessment: <br/ ><br>Safety assessments include measurement and monitoring of vital signs, physical examination, weight examination, injection site reaction assessment, evaluation of severity of illness by assessing Clinical Global Impression â?? Severity of illness (CGI-S) scale, adverse events assessment and clinical laboratory assessment. <br/ ><br>Timepoint: 540 Days