A clinical trial intended to compare Bioequivalence of two formulations of Aripiprazole Injectable suspension 400 mg in adult patients with Schizophrenia.
- Conditions
- Health Condition 1: F208- Other schizophrenia
- Registration Number
- CTRI/2022/02/039943
- Lead Sponsor
- Pharmathen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subjects will be eligible for inclusion in this study only if all of the following criteria apply:
1.Male or non-pregnant, non-lactating female patient between 18 and 64 years of age (both inclusive).
2.Patient with documented diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders – 5th edition (DSM-V) or latest version criteria. (refer Appendix VII).
3.Patient with Body Mass Index (BMI) =18 to <30 kg/m2 and weight not less than 50 kg.
4.Patient who is clinically stable and had no hospitalisation for exacerbation of psychiatric symptoms during the 3 months before screening and till randomisation.
5.Patient on stable oral aripiprazole 10-20 mg who require chronic anti-psychotic treatment and who will benefit from initiating treatment with Aripiprazole for Extended-Release Injectable suspension for intramuscular use 400 mg (Single dose vial).
6.Patient and LAR must demonstrate adequate decision-making ability to make an informed decision about participating in this study by providing written informed consent.
7.Patient who agrees to comply with the visit schedule and other requirements of the study.
8. Patients must have an identified support person (e.g. family member, case worker, social worker) considered reliable by the investigator to help ensure compliance with study treatment and visits and to alert staff of any issues of concern.
Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
1. Patient with known or suspected allergy or hypersensitivity to aripiprazole or any other ingredients of the formulation.
2. Patient having signs and symptoms suggestive of COVID-19 (such as fever, dry cough, difficulty in breathing, fatigue etc.).
3. Positive pregnancy test.
4. Patients having allergic diathesis or any clinically significant allergic disease (i.e. asthma or bronchial hyperreactivity).
5. Patients having any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug.
6. Administration of depot injectable solutions or medications with a half-life > 1 week (including study medications) within 6 months before screening visit.
7. History of medically significant adverse events or intolerance with aripiprazole based on investigator’s discretion.
8. Any concomitant medicinal products known to have clinically important interactions with aripiprazole such as strong CYP3A4 Inhibitors (e.g. ketoconacole) or strong CYP2D6 inhibitors (e.g. paroxetine, fluoxetine), strong CYP3A4 inducers (e.g. carbamazepine), antihypertensive drugs, and benzodiazepines (e.g. lorazepam). ?
9. Patient who is poor metaboliser of CYP2D6 enzyme.
10. Patient with Clinical Global Impression – Severity of illness (CGI-S) score of 5 or more.
11. Patient with inadequate muscle mass to receive the intramuscular injection according to the investigator.
12. Patient with a history of Neuroleptic Malignant Syndrome (NMS) or tardive dyskinesia while on treatment with atypical anti-psychotics.
13. Patient with dementia related psychosis.
14. Patient with history or presence of pathological gambling and other compulsive behaviours.
15. Patient with history or presence of seizures or other conditions that potentially lower the seizure threshold.
16. Presence of significant orthostatic hypotension (i.e. decrease in systolic blood pressure =20 mmHg or diastolic BP of =10 mmHg when comparing standing to supine values) or uncontrolled hypertension (systolic BP =150 mmHg/diastolic BP = 100 mmHg).
17. Patient with known cardiovascular disease (example, heart failure, history of myocardial infarction or ischaemia), cerebrovascular disease, or conditions that predispose the patient to hypotension (example, dehydration, hypovolemia, and treatment with anti-hypertensive medications), uncontrolled metabolic disorders including uncontrolled hyperglycaemia/diabetes mellitus (HbA1c = 9 %) or dyslipidaemia, hepatic, neurological, haematological, renal, gastrointestinal and other major systemic disease that in the judgement of the investigator would interfere with trial, require treatment or make implementation or interpretation of the trial results difficult.
18. Patient with a history of a corrected QT interval > 450 ms (Bazett’s formula) (as per Appendix V).
19. Patient with history of drug induced leukopenia/ neutropenia/ agranulocytosis.
20. Patient with abnormal haematological parameters at screening and randomisation defined by:
a. Total white blood cell count < 4000/mm3
b. ANC < 1500/mm3
c. Platelet count < 100,000/mm3
d. Haemoglobin < 9.0 gm/dl
21. Patient with abnormal liver function tests at screening and randomis
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the Pharmacokinetic (PK) parameters that pertain to the rate and extent of absorption of Aripiprazole for extended-release injectable suspension 400 mg of Pharmathen S.A to Abilify Maintena 400 mg to determine whether these two formulations are bioequivalent in schizophrenic patients. The rate and extent of absorption of Aripiprazole in PK samples will be measured.Timepoint: 48 weeks - Post Randomization. <br/ ><br>Once a steady state is reached, full PK profiling of both products shall be obtained after the 5th and 6th injection of each respective period. <br/ ><br>
- Secondary Outcome Measures
Name Time Method To check the safety and tolerability of Aripiprazole of Pharmathen S.A 400 mg and Abilify Maintena 400 mg for intramuscular use. <br/ ><br> <br/ ><br>Safety assessment will be based on adverse events, vital signs, physical examination, laboratory tests, (hematology, blood biochemistry, Electrolyte, urine testing), evaluation of suicidal behavior, and electrocardiogram (ECG) results. <br/ ><br>Timepoint: Around 63 weeks of study duration