CTRI/2017/02/007884已完成不适用
A randomized, multi center, open label, balanced, two-treatment, three-period, three-sequence, multiple dose, partial replicate crossover, steady-state bioequivalence study of Paliperidone prolonged-release 9 mg tablets of Pharmathen S.A., Greece in comparison with INVEGA 9 mg prolonged-release tablets (Marketing Authorisation Holder: Janssen-Cilag International NV Belgium) in adult schizophrenic patients under fasting conditions.
Pharmathen SA Greece6 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2017年1月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- To demonstrate bioequivalence of paliperidone prolonged 9 mg tablet of Pharmathen S.A Greee VS. in comparison with
研究概览
简要总结
The patients with confirmed diagnosis of Schizophrenia who are candidates for paliperidone prolong released (9 mg tablet) and who fulfill the inclusion and exclusion criteria will be randomized in study. As per randomization schedule, patient will receive test product once and reference product twice during three treatment periods, patient will be randomized to one of the three treatment sequences,i.e. TRR,RTR or RRT in each period cross over without wash out period.
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.Men and women aged 18-65 years (both inclusive) having clinical diagnosis of schizophrenia (DSM IV-TR).
- •2.Have body mass index of 18.5 to 30kg/m
- •3.Schizophrenic patients who are on stable dose of paliperidone9 mg prolonged-release tablet once daily or clinically indicated to receive paliperidone9 mg prolonged-release tablet once daily as per Investigator’s opinion.
- •4.Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, 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 study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during the study and up to 30 days after the last dose of study drug.
- •And Sexually active women must have a negative pregnancy test (at screening, before check-in on day 0) as well as must be non-lactating at screening.
- •5.In case of male patients: Either partner or patient must agree to use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during the study and up to 30 days after the last dose of study drug.
- •6.Willing and able to comply with housing, restrictions and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.
- •7.Adequate hematological parameters at screening defined by: Total white blood cell count  4000/c.mm ANC  1500/mm3 Platelet count  75,000/mm3 Haemoglobin ≥ 9.0 gm/dl 8.Adequate hepatic function at screening as defined by: Bilirubin ≤ 1.5 X ULN (upper limit of normal) AST/ ALT ≤ 2.5 X ULN 9.Adequate renal function at screening as defined by S.
- •creatinine ≤1 X ULN or creatinine clearance ≥80 ml/min.
排除标准
- •1.A history of allergic reactions/hypersensitivity to the active substance (paliperidone), risperidone or other excipients of study drug.
- •2.Subject with history of hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period.
- •3.Concurrent primary psychiatric (other than schizophrenia) or neurological diagnosis, including neurologic malignant syndrome, organic mental disorder, severe tardive dyskinesia, Parkinson’s disease, history or presence of epilepsy or risk for seizures, history of multiple syncopal episodes.
- •4.Subject who is having : Clinically significant cardiac disorders (e.g. myocarditis, cardiomyopathy, bradycardia) or QTc> 500 milliseconds or Uncontrolled hypertension.
- •Gastrointestinal obstruction, narrowing (pathological or iatrogenic), significantly difficulty in swallowing tablet, colonic disease, condition leading to shorter gastrointestinal transit time (e.g. diseases associated with chronic severe diarrhea).
- •Myeloproliferative disorders (drug-induced or idiopathic).
- •Significant orthostatic hypotension at screening or before check-in on day 0; orthostatic hypotension will be considered when there is drop in systolic blood pressure of 30 mm Hg or more or diastolic blood pressure of 20 mm Hg or more on standing from supine measurements.
- •Presence of uncontrolled metabolic disorders including diabetes mellitus (HbA1c > 9%).
- •Significant hyperprolactinaemia or with possible prolactin-dependent tumours.
- •History/presence of venous thromboembolism.
- •5.Expected changes in concomitant medications during the period of study.
- •6.History of alcohol or drug abuse.
- •7.Positive urine drug scan test (for drugs) or alcohol breath test (for alcohol abuse) at screening or baseline.
- •8.A history of alcohol or drug dependence by Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria during the 6-month period immediately prior to study enrollment.
- •9.Use of any of the following medications within 14 days prior to enrolment but not limited to: Medications known to prolong the QTc interval, [As mentioned in Annexure III] Medicines known to lower the seizure threshold (i.e.,carbamazepine,phenothiazines or butyrophenones, clozapine, tricyclics or SSRIs, tramadol, mefloquine, etc.) Other medicinal products or herbals which are strong inducers of CYP3A4, e.g. rifampicin and St John´s wort (Hypericumperforatum) Medicinal products affecting gastrointestinal transit time.
- •e.g., metoclopramide.
- •Divalproex sodium Antihypertensive and other drugs known to cause postural hypotension.
- •Alcohol, MAOIs, CNS depressants including narcotics and benzodiazepines Use of other drugs known to suppress bone marrow function 10.A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Paliperidone.
- •11.Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
- •12.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
- •13.Chronic Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
- •14.History of difficulty with donating blood or difficulty in accessibility of veins.
- •15.Compliance with outpatient medication schedule not expected as per Principal Investigator’s opinion.
- •16.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
- •17.Participation in any clinical study within the past 30 days of randomization or has less than 5 half life from previous IMP receipt.
- •18.An unusual or abnormal diet, for whatever reason planned e.g. religious fasting during the course of the study.
- •19.Any condition/ abnormal baseline findings that in the Investigators’ judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study e.g. low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study.
结局指标
主要结局
To demonstrate bioequivalence of paliperidone prolonged 9 mg tablet of Pharmathen S.A Greee VS. in comparison with
时间窗: A total of 60 PK samples will be collected during the study. Safety assessment on Day 19 and post safety assessment on Day 28 should be collected.And after that evaluation of the sampling done.
INVEGA 9 mg prolonged release tablets by Janssen Ciag International NV Belgium.
时间窗: A total of 60 PK samples will be collected during the study. Safety assessment on Day 19 and post safety assessment on Day 28 should be collected.And after that evaluation of the sampling done.
次要结局
- To monitor the safety and tolerability profile of the study formulation.(NA)
研究者
研究点 (6)
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