CTRI/2022/11/046945 [Registered on: 01/11/2022] Trial Registered Prospectively
Last Modified On:
30/01/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioequivalence study of Aripiprazole for 400 mg in patients with schizophrenia or bipolar I disorder under fasting condition.
Scientific Title of Study
A randomized, open-label, multicenter, balanced, two-treatment, two-period, two-sequence, multiple-dose, steady-state, crossover, bioequivalence study of Aripiprazole for extended-release injectable suspension 400 mg of Qilu Pharmaceutical Co., Ltd. with that of 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.
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
CBCC/2022/007 Version 1.0 dated: 21/Apr/2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sandeep Singh
Designation
Vice President - Clinical Operations
Affiliation
CBCC Global Research LLP
Address
Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210,
India
Bodakdev Ahmadabad GUJARAT 382210 India
Phone
9637555304
Fax
Email
sandeep.singh@cbccusa.com
Details of Contact Person Scientific Query
Name
Dr Sandeep Singh
Designation
Vice President - Clinical Operations
Affiliation
CBCC Global Research LLP
Address
Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210,
India
Bodakdev
GUJARAT 382210 India
Phone
9637555304
Fax
Email
sandeep.singh@cbccusa.com
Details of Contact Person Public Query
Name
Dr Sandeep Singh
Designation
Vice President - Clinical Operations
Affiliation
CBCC Global Research LLP
Address
Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210,
India
Bodakdev
GUJARAT 382210 India
Phone
9637555304
Fax
Email
sandeep.singh@cbccusa.com
Source of Monetary or Material Support
Qilu Pharmaceutical Co., Ltd.
No.23999 Gong Ye Bei Road, Jinan,
Shandong, China 250100
Primary Sponsor
Name
Qilu Pharmaceutical Co Ltd
Address
No.23999 Gong Ye Bei Road, Jinan,
Shandong, China 250100
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
CBCC Global Research LLP
Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210, India
Institutional Ethics Committee SRIHER Sri Ramachandra Hospital
Approved
Institutional Ethics Committee Sunshine Global Hospital
Approved
J.K. Orthopaedic Hospital Ethics Committee
Approved
Kingsway Hospitals Ethics Committee
Approved
Magna-care Ethics Committee
Approved
Pagarav Ethics Committee
Approved
Rudraksha Hospital Ethics Committee
Approved
Shivam Ethics Committee
Approved
Yash Societys Sujata Birla Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: F312||Bipolar disorder, current episodemanic severe with psychotic features,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
ABILIFY MAINTENA® (aripiprazole) for extended release injectable suspension 400 mg of Otsuka Pharmaceutical Co. Ltd.
Dosage: Multiple Intramuscular Dose of 400 mg, Frequency: Once in 28 days, Route of Administration: Intramuscular, Duration of Therapy: 6 Dose
Intervention
Aripiprazole for extended-release injectable suspension, 400 mg of Qilu Pharmaceutical Co., Ltd.
Dosage: Multiple Intramuscular Dose of 400 mg,
Frequency: Once in 28 days,
Route of Administration: Intramuscular,
Duration of Therapy: 6 Dose
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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. Intrauterine device (IUD) or intrauterine system
c. 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
ExclusionCriteria
Details
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.
8. Patients with history or presence of dysphagia
9. Patients with clinically significant uncontrolled dyslipidemia
10. 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.
21. 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).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
To monitor the adverse events and to ensure the safety of patients after investigational product (IP) administration
337 Days
Target Sample Size
Total Sample Size="90" Sample Size from India="90" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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 for
extended-release injectable suspension 400 mg of Qilu Pharmaceutical Co., Ltd.
with that of 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.