An Open-Label, Randomized, Two-Way Crossover, Multiple Dose, Comparative Bioavailability study of Aripiprazole ER IS (400 mg) in patients with schizophrenia.
- Conditions
- Health Condition 1: F20- Schizophrenia
- Registration Number
- CTRI/2022/06/043537
- Lead Sponsor
- Apotex Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
1.Males and females 18-65 years of age.
2.Patient and legally acceptable representative (LAR: e.g. family member) willing and able to provide written Informed Consent and comply with the requirements of the study.
3.Diagnosed with schizophrenia, as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), in a non-acute (e.g., chronic) phase and clinically stable in the judgment of the Investigator for at least 8 weeks before Screening.
4.At time of Screening be on a stable regimen of aripiprazole ER injection (400 mg) for at least 8 weeks before Screening or aripiprazole oral 10 mg- 20 mg daily for at least 8 weeks before Screening.
5.General health status acceptable per judgment of the Investigator for participation in this clinical study with no hospitalizations for medical conditions within 12 weeks before and during Screening. Any question regarding general health status eligibility will be addressed with the Medical Monitor.
6.Female patients with childbearing potential must have a negative serum pregnancy test at Screening and at Baseline (Day -1), or must be postmenopausal (amenorrhea for at least 2 years and follicle-stimulating hormone [FSH] > 40 mIU/mL), or surgically sterile (for one year), or practicing or agree to practice an effective method of birth control if they are sexually active before study entry, during the study and 3 months after the end of the study by using an acceptable method of contraception. Acceptable methods of birth control must be used for at least 30 days prior to the use of study drug. Acceptable methods of birth control include abstinence, oral, vaginal or patch contraceptive, copper intrauterine device, or double-barrier method (e.g., condom, diaphragm or cervical cap with spermicidal foam, cream, gel or suppository).
7.Body mass index of 18.0-38.0 kg/m2 inclusive.
8.No clinically significant abnormal laboratory values.
9.No clinically significant findings in the 12-lead electrocardiogram (ECG).
10.No clinically significant findings from a vital sign measurement.
11.Patients must have an identified support person as LAR considered reliable by the Investigator to help ensure compliance with study treatment and visits and to alert staff of any issues of concern.
12.Patients must have a stable place of residence for the 3 months prior to Screening.
13.Patients must not have been either hospitalized for worsening of schizophrenic symptoms or judged by the Investigator as having significant exacerbation of schizophrenic symptoms during the 3 months prior to Screening.
1.Patients with a primary and active DSM-5 diagnosis other than schizophrenia.
2.Patients currently on aripiprazole lauroxil (Aristada).
3.Have a known hypersensitivity to aripiprazole or to any excipients in the formulation.
4.Patients who pose a significant risk of a suicide attempt based on history or the Investigator’s judgment, or who answer yes ? to Suicidal Ideation items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) for current or past 30 days on the Baseline/Screening version ? at Screening or Since Last Visit version ? at Baseline, or who have suicidal behavior in the last 12 months as measured by the C-SSRS at Screening or Baseline; or are at imminent risk of suicide or violent behavior based on the Investigator’s clinical assessment or the C-SSRS assessment of lifetime suicidal ideation or behavior at screening.
5.Patients with a history of neuroleptic malignant syndrome or tardive dyskinesia, or a history of severe akathisia or severe extra-pyramidal reactions such as dystonia with previous use of aripiprazole or other neuroleptic treatments, or a score of 4 or above on the Global Clinical Assessment of the Barnes Akathisia Rating Scale (BARS) at Screening.
6.Patients with uncontrolled diabetes mellitus, or a HbA1c level = 7%, or with diabetes mellitus requiring use of insulin. Patients with newly diagnosed Type 2 diabetes during the screening period are excluded, however stable (30 days or longer) Type 2 diabetes will be allowed.
7.Patients with a history of or who are currently diagnosed as having epilepsy or convulsion disorders.
8.Patients who are CYP2D6 poor metabolizers.
9.Patients who used medication known to be a potent or moderate inhibitor of CYP 2D6, or potent inhibitor of CYP 3A4 or a potent inducer of CYP 3A4 within 30 days or 5 PK half-lives for the specific medication, whichever is longer, prior to Screening or between Screening and Baseline visit (Day -1). Patients who used monoamine oxidase (MAO) Inhibitors 30 days prior to screening or between screening and baseline visit (Day -1).
10.Patients who regularly consume grapefruit or Seville oranges.
11.Patients meeting DSM-5 criteria for moderate or severe alcohol or substance use disorder (other than nicotine- or caffeine-related disorders) within 6 months of Screening or test positive for a drug of abuse or alcohol at Screening or Baseline (except positive findings that can be accounted for by documented prescription use prescribed by a treating clinician as a part of the treatment for the patient’s acute medical condition (i.e., tooth extraction).
12.Patients with a history of, or current clinically relevant cardiac arrhythmia, cardiovascular disease, thyrotoxicosis, parkinsonism, or hemorrhagic diathesis.
13.Patients who have a history of malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
14.Female patients who are pregnant or tested positive for pregnancy at Screening or Baseline, or are breastfeeding, or are of childbearing potential without adequate use of contraception.
15.Patients who have any uncontrolled, unstable clinically relevant medical condition (e.g. hepatic, renal, cardiovascular, endocrine, respiratory, hematologic, immunologic or cerebrovascular disease), or other medical condition, which in the judgment of the Invest
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the comparative bioavailability of aripiprazole ER IS (400 mg) (Test) to Abilify Maintena® (aripiprazole) ER IS (400 mg) (Reference).Timepoint: EOS Day 336
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of aripiprazole - Test in comparison to Abilify Maintena - Reference by evaluating the nature, severity, and frequency of their AE profiles and local skin reactions.Timepoint: Time-Point <br/ ><br>Approximately 48 weeks of Study duration <br/ ><br>