CTRI/2022/02/040103招募中不适用
A Randomized, Open Label, Multicenter, Two-treatment, Single-period, Multiple Dose, Parallel, Steady State Bioequivalence Study of Paliperidone Palmitate (3-month) Extended Release Injectable Suspension for intramuscular use 546 mg (350 mg Paliperidone) (Pharmathen S.A., Greece) compared to TREVICTA® 350 mg Prolonged Release Suspension for injection (Janssen-Cilag International NV, Belgium) in adult schizophrenic patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 284
- 试验地点
- 15
- 主要终点
- To assess the bioequivalence of the Test Product Paliperidone palmitate (3-month) extended release injectable suspension for intramuscular use 546 mg (350 mg Paliperidone) with respect to the Reference Product TREVICTA®350 mg prolonged release suspension for injection in adult schizophrenic patients.
研究概览
简要总结
Upon entering into the study, patients will receive the Injection PaliperidonePalmitate extended release injectable suspension for intramuscular use 546 mg(350 mg Paliperidone) Intra muscularly (Deltoid site) every 3 months for atotal of 4 doses at ambient temperature as per randomization schedule (either the test orreference product) in a parallel design. Investigational product administration will be done bythe trained study personnel under the supervision of the investigator.
- During the Stabilization period, patients will receive monthly-doses of an approved marketed version of paliperidone palmitate 156 mg (100 mg Paliperidone) extended release injectable suspension. Details of the same will be included in IMP plan.
- After the study is completed (after last PK sample collection on Day 361), patients may be continued on their current dose of Paliperidone using an approved paliperidone product as prescribed by their clinicians.
- Administration shall be performed on alternating body sides (left andright) for each injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or non-pregnant, non-lactating females aged 18-65 years (inclusive) having a documented clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V).
- •2.Written informed consent for participation in the study by the patient and patient’s legal acceptable representative (LAR) and willing to adhere to protocol requirements.
- •3.Patients having BMI between 18-35 kg / m2 and at least 50 kg weight for male patients and 48 kg for female patients.
- •4.Patients who at screening are at a stable regimen of oral Paliperidone or Risperidone therapy or who are already receiving Paliperidone palmitate 156 mg (100 mg Paliperidone) extended release injectable suspension and who at randomization are receiving a stable regimen of 156 mg (100 mg Paliperidone) of monthly paliperidone palmitate extended release suspension via the intramuscular route.
- •5.Patients who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms for at least 3 months before randomization.
- •6.Patients having Clinical Global Impression scale score of ≤ 4 at both screening and Baseline visits.
- •7.Patients not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening 8.Adequate organ and bone marrow function at screening and randomization defined by: Bone marrow function: a)Total white blood cell count≥ 4000/mm3 b)ANC ≥1500/mm3 c)Platelet count ≥ 100,000/mm3 d)Hemoglobin ≥ 9gm/dl Hepatic function: Bilirubin <1.5 X ULN AST & ALT <5 X ULN Renal function: Creatinine clearance more than or equal 80 mL per min (Calculated based on Cockcroft-Gault formula) 9.Patients able to comply with study procedures in the opinion of the investigator.
- •10.In case of Male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during the study and up to 90 days after the last PK sample collection.
- •Cessation of birth control after this point should be discussed with a responsible physician.
- •11.Women of non child bearing potential with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy at least 6 months prior to IMP administration) or postmenopausal for at least 12 consecutive months.
- •OR Women of child bearing potential must have negative pregnancy test at screening visit and before randomization and must agree to use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to IMP administration] sexual partner) for at least 4 weeks prior to IMP administration, during the study and up to 90 days after the last dose of IMP.
- •Cessation of birth control after this point should be discussed with a responsible physician Note: It is the investigator’s responsibility to ensure that the above points regarding an effective method of avoiding pregnancy are discussed with the patient/LAR in detail and patient agrees with this and this is documented in source document.
- •The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per the protocol.
排除标准
- •1.Patients with known hypersensitivity/ intolerance to study drug or any other component of the drug or intolerance to oral paliperidone/risperidone prior to screening.
- •2.Patients with a history of Neuroleptic Malignant Syndrome (NMS) while on treatment with antipsychotics.
- •3.History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with use of drugs that prolong QTc interval, including: bradycardia, cardiac arrhythmias, hypokalemia or hypomagnesemia, concomitant use of other drugs that known to prolong the QTc interval, and prolonged QT interval (QTc> 450 msec in male patients or QTc> 470 msec in female patients, QTc interval to be calculated with Bazett’s Formula, at screening and randomization.
- •6.Patients with concurrent condition of Parkinsons disease except for drug-induced extrapyramidal syndrome.
- •Patients with history or presence of tardive dyskinesia.
- •Patients with cognitive and motor impairment.
- •7.Patients with concomitant treatment with hepatic enzyme inhibitors (including fluoxetine or paroxetine) or medications known to interact with study medication within 2 weeks of the first injection of study medication.
- •Note: If the patient was on any of these drugs, sufficient wash out period (of at least 5 half- lives) must have elapsed since the last dose of such drug and the first dose of study medication.
- •8.Treatment with any of the following therapies: •Injection of risperidone long acting injection within 6 weeks before randomization.
- •â€¢Electroconvulsive therapy within 3 months prior to screening.
- •â€¢Clozapine within 3 months before screening 9.Presence of syncope or orthostatic hypotension (defined as systolic blood pressure decrease of at least 30 mmHg or a diastolic blood pressure decrease of at least 20 mmHg within one to three minutes of standing up).
- •10.Patients with uncontrolled hypertension (systolic BP more than or equal to 150 mmHg/diastolic BP more than or equal to 100 mmHg).
- •11.Patients with known cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration, hypovolemia and treatment with antihypertensive medications).
- •12.Patients with inadequate mass in the deltoid regions to receive the intramuscular drug injection.
- •13.Patients with severe hepatic impairment based on the Child-Pugh classification (Child-Pugh category C).
- •14.Patients with a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period prior to screening.
- •16.Patient attempted suicide within 12 months before screening or current thoughts of suicide (suicidal ideation) or violent tendencies/ behavior as clinically assessed by the investigator.
- •17.Patients found positive for HIV, Syphilis, Hepatitis B surface antigen or Hepatitis C antibody at screening.
- •18.A history of granulocytopenia, agranulocytosis or myeloproliferative disorders (drug-induced or idiopathic).
- •19.Patient positive on Breath alcohol analyzer test at the time of visit at screening and/or baseline.
- •20.Treatment with any investigational drug in the last 3 months (or 5 half-lives, whichever is longer) before signing the informed consent.
- •Note: Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study.
- •21.Psychosis judged to be the direct physiological effect of an abused medication or substance.
- •22.Patients with the following cardiac conditions: •Recent myocardial infarction (<12 months) •First-degree heart block with PR interval > 0.22 seconds.
- •â€¢Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia •Uncompensated congestive heart failure, myocarditis, cardiomyopathy •Complete left bundle branch block.
- •Patients with seizures or other conditions that potentially lower the seizure threshold.
- •25.Patients with hyperprolactinemia or with possible prolactin dependent tumor at screening visit which as judged by the Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
- •26.Patients with dementia related psychosis.
- •27.Concurrent use of other drugs known to suppress bone marrow function.
- •28.Patients with ongoing clinically significant adverse event(s) due to prior treatments administered, as determined by the investigator.
- •29.Patients who, in the opinion of the Investigator, will not be compliant with the requirements of the study procedures.
- •31.Positive on urine test for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine) prior to receiving the first dose of investigational medicinal product in the study.
- •32.Patients who are on active treatment with drugs that are known to interact with paliperidone (List of Allowed and Prohibited Medications Provided in Appendix IV).
- •Note: If the patient was on any of the prohibited medications outlined in Appendix IV, sufficient wash out period (of at least 5 half-lives) must have elapsed since the last dose of such drug and the first dose of study medication.
结局指标
主要结局
To assess the bioequivalence of the Test Product Paliperidone palmitate (3-month) extended release injectable suspension for intramuscular use 546 mg (350 mg Paliperidone) with respect to the Reference Product TREVICTA®350 mg prolonged release suspension for injection in adult schizophrenic patients.
时间窗: A total of 42 blood samples each of 03 mL will be collected from each patient for PK assessment during the study.All the post-dose PK blood samples till 48.00 hr. should be collected within ± 2 minutes from the scheduled sampling time.
次要结局
- To monitor the safety and tolerability profile of the two formulations.(AtScreening, Day 46 ± 7 days ,Day 136 ± 7 days ,Day 226 ± 7 days, at each dosing and EOS visit, there will be physical examination,vitals signs will be performed by investigator.)
研究者
研究点 (15)
Loading locations...
相似试验
进行中（未招募）
不适用
Two-treatment Bioequivalence Study of Paliperidone Palmitate in adult schizophrenic patientsCTRI/2023/06/054479American Regent, Inc.170
尚未招募
不适用
A study of Paliperidone Palmitate injection in patients of abnormal behaviorCTRI/2019/01/016865Accord Healthcare Inc240
尚未招募
不适用
A comparative study to monitor the safety of Amphotericin 50mg per vial A and Ambisome (amphotericin b) 50 mg per vial B in 48 patients.CTRI/2017/03/007993Sun Pharmaceutical Industries Limited48
已完成
不适用
Azathioprine Bioequivalence study in Rheumatoid ArthritisRheumatoid ArthritisCTRI/2010/091/000070Orion Pharma42
招募中
不适用
multicenter, open label, three periods, three sequence single dose bioequivalence study of Doxorubicin Injection in female patients with ovarian cancerCTRI/2021/03/032185ForDoz Pharma Corp51