CTRI/2017/02/007884已完成未知
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. - 16-VIN-0596
Pharmathen SA Greece0 个研究点目标入组 87 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 87
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
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/m2.
- •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 Investigatorââ?¬•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.
- •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 ïâ??³ 4000/c.mm
- •ANC ïâ??³ 1500/mm3
- •Platelet count ïâ??³ 75,000/mm3
- •Haemoglobin ââ?°Â¥ 9.0 gm/dl
- •8.Adequate hepatic function at screening as defined by:
- •Bilirubin ââ?°Â¤ 1.5 X ULN (upper limit of normal)
- •AST/ ALT ââ?°Â¤ 2.5 X ULN
- •9.Adequate renal function at screening as defined by S. creatinine ââ?°Â¤1 X ULN or creatinine clearance ââ?°Â¥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, Parkinsonââ?¬•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 JohnÃ?´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.
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