Bioequivalence study of Aripiprazole for 400 mg in patients with schizophrenia or bipolar I disorder under fasting condition.

Active, not recruiting

• Conditions: Bipolar disorder, current episodemanic severe with psychotic features,

• Registration Number: CTRI/2022/11/046945
• Lead Sponsor: Qilu Pharmaceutical Co Ltd

Brief Summary

This is a randomized, open-label,multicenter, balanced, two-treatment, two-period, two-sequence, multiple-dose,steady-state, crossover, bioequivalence study of Aripiprazole forextended-release injectable suspension 400 mg of Qilu Pharmaceutical Co., Ltd.with that of ABILIFY MAINTENA® (aripiprazole) for extended release injectablesuspension 400 mg of Otsuka Pharmaceutical Co. Ltd. in patients withschizophrenia or bipolar I disorder under fasting condition.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-12
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Subjects will be considered eligible for the study based on the following criteria: 1.
• Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements 2.
• Male or female patient between 18 and 65 years of age (both inclusive) having body mass index (BMI) between 18.50 to 30.00 kg per m2 (both inclusive) 3.
• Patients with diagnosis of schizophrenia or bipolar I disorder as per DSM-V-TR criteria or later [Appendix A] 4.
• Patients who are already receiving a stable regimen of Aripiprazole for extended-release injection 400 mg every four weeks via the intramuscular route and have received at least 2 prior documented doses of Aripiprazole for extended-release injection 400 mg prior to randomization Note: For patients who will enter in to the Lead-in period, the criteria will be evaluated during screening Part-II 5.
• Acceptable hematology status: a.
• Hemoglobin greater than or equal to 9 g per dL b.
• Absolute neutrophil count (ANC) greater than or equal to 1500 cells per micro liter c.
• Platelet count greater than or equal to 100,000 cells per micro liter d.
• White blood cell count (WBC) greater than or equal to 4000 cells per micro liter 6.
• Acceptable liver function: a.
• Alanine aminotransferase (ALT) less than or equal to 2 X upper limit of normal (ULN) b.
• Aspartate aminotransferase (AST) less than or equal to 2 X ULN c.
• Bilirubin less than or equal to 1.5 mg per dL d.
• Alkaline phosphatase less than or equal to 2 X ULN 7.
• Female patients with negative urine pregnancy test on Day 01 and serum pregnancy test at screening 8.
• Female of child bearing potential, (defined as female physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing two acceptable methods of contraception.
• Acceptable methods of contraception are: a.
• Oral, parenteral (injection), patch, or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of IP b.
• Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent) d.
• Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) e.
• Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation f.
• Total abstinence; partial abstinence is not acceptable 9.
• No history of addiction to any recreational drug or drug dependence or alcohol addiction.

Exclusion Criteria

• Subjects will be excluded from the study based on the following criteria: 1.
• Hypersensitivity to aripiprazole or related class of drugs or to any of the excipients of the formulation 2.
• Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening 3.
• Corrected QT interval [Fridericia formula (QTcF)] >450 msec (male) or >470 msec (female) at screening 4.
• Patients with history or presence of Neuroleptic Malignant Syndrome (NMS) or Tardive dyskinesia while on treatment with atypical antipsychotic 5.
• Patients with history or presence of cognitive or motor impairment or pathological gambling or other compulsive behaviour 6.
• Patients with history or presence of dementia related psychosis 7.
• Patients with history or presence of seizure or other conditions that potentially lower the seizure threshold.
• Patients with history or presence of dysphagia 9.
• Patients who are on active treatment with drugs that are known to interact with aripiprazole (such as strong CYP2D6 inhibitors, CYP3A4 enzyme inducers or inhibitors).
• [Appendix B] 11.
• Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day 12.
• Major surgical procedure (including periodontal) within 28 days of first dose of IP 13.
• Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) 14.
• History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment etc.) 15.
• Participation in any clinical study within 90 days before the first dose of IP 16.
• Patients with positive urine screen for drugs of abuse (except for benzodiazepine which is a permissible medication supported by written prescription) 17.
• Patients with positive urine alcohol test 18.
• Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 20 mm Hg or more and/or a drop in diastolic blood pressure of 10 mm Hg or more within 3 minutes of standing) or history of syncope at screening 19.
• Patients with skin abnormalities/irritations at the injection site as determined by the Investigator 20.
• Patients with any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study that would limit adherence to study requirements.
• Lactating women 22.
• Loss of greater than or equal to 350 mL of blood within 90 days before the first dose of IP 23.
• Patients with confirmed novel coronavirus infection (COVID-19).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the steady-state bioequivalence of Aripiprazole for extended-release injectable suspension 400 mg of Qilu Pharmaceutical Co., Ltd. with ABILIFY MAINTENA® (aripiprazole) for extended release injectable suspension 400 mg of Otsuka Pharmaceutical Co. Ltd. in patients with schizophrenia or bipolar I disorder under fasting condition.	337 Days

Secondary Outcome Measures

Name	Time	Method
To monitor the adverse events and to ensure the safety of patients after investigational product (IP) administration	337 Days

Trial Locations

Locations (12)

Anand Multispecialty Hospital & Research Centre; 🇮🇳 Gandhinagar, GUJARAT, India

Assured Care Plus Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Chopda Medicare and Research Centre Pvt. Ltd.; 🇮🇳 Nashik, MAHARASHTRA, India

Divine Multispeciality Hospital; 🇮🇳 Gandhinagar, GUJARAT, India

J.K Orthopaedic Hospital; 🇮🇳 Kantha, GUJARAT, India

KIMS-Kingsway Hospitals; 🇮🇳 Nagpur, MAHARASHTRA, India

NRR Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Parth Hospital; 🇮🇳 Kheda, GUJARAT, India

Shivam Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Shri Hatkesh Healthcare Foundation; 🇮🇳 Junagadh, GUJARAT, India

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Anand Multispecialty Hospital & Research Centre

🇮🇳Gandhinagar, GUJARAT, India

Dr Rajendra Anand

Principal investigator

9824017400

drrajendraanand@yahoo.com