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临床试验/CTRI/2011/08/001949
CTRI/2011/08/001949已完成未知

A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO-TREATMENT, TWOSEQUENCE, CROSS-OVER, STEADY-STATE BIOEQUIVALENCE STUDY OF QUETIAPINE FUMARATE TABLETS 300 MG MANUFACTURED BY AMNEAL (TEST) WITH SEROQUEL® (QUETIAPINE FUMARATE) 300 MG TABLETS MANUFACTURED BY ASTRAZENECA (REFERENCE) IN ADULT SCHIZOPHRENIC PATIENTS ALREADY RECEIVING/ STABILIZED WITH QUETIAPINE - NI

Amneal Pharmaceuticals LLC0 个研究点目标入组 42 人开始时间: 待定最近更新:
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试验速览

阶段
未知
状态
已完成
入组人数
42
研究概览入排标准研究者记录与标识符相似试验

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. Adult schizophrenic patients with body mass index (BMI) between 18 and
  • •35kg/m2, inclusive, and aged between 18 and 60 years, inclusive. on stable
  • •regimen with Quetiapine 300 mg IR preparation Q12h
  • •2. Confirmed by a psychiatrist according to the Diagnostic and Statistical Manual IV
  • •(DSM IV) criteria
  • •3. Able to comprehend the full nature and purpose of the study, including possible
  • •risks and adverse events; ability to co-operate with the investigator and to
  • •comply with the requirements of the entire study
  • •4. Signed written informed consent prior to inclusion in the study witnessed by a
  • •legally acceptable representative or guardian
  • •5. Should be otherwise healthy as determined by physical examination, medical
  • •history, and no significant abnormality in any of the laboratory parameters
  • •including ECG and Chest X-ray
  • •6. Body weight ≥ 45kgs
  • •7. Adequate hemoglobin i.e. ≥10gm/dL
  • •8. Adequate renal function at screening as defined by Creatinine 1.5 X ULN for the
  • •clinical laboratory
  • •9. Female patients of childbearing potential must be willing to use a reliable method
  • •of birth control, i.e. barrier method, intrauterine device, etc. during the study.

排除标准

  • •1. Known to have significant orthostatic hypotension
  • •2. Known to have tachycardia or tachyarrhythmia
  • •3. Bouts of uncontrolled seizures
  • •4. Concurrent primary psychiatric or neurological diagnosis, including organic mental
  • •disorder, severe tardive dyskinesia, idiopathic Parkinson¡¯s disease or Alzheimer¡¯s
  • •5. Used any investigational drug within 3 months before Screening
  • •6. On anticoagulants
  • •7. Blood donations/ losses within 60 days of Screening
  • •8. history of arrhythmias, hypokalemia, hypomagnesemia, or congenital QT
  • •prolongation History of multiple syncopal episodes
  • •9. History of alcoholism within 3 months prior to Screening
  • •10. History of drug abuse or dependence within 3 months prior to Screening
  • •11. A value at Screening is greater than 1.5 times the upper limit of reference range
  • •for AST, ALT, direct bilirubin, total triglycerides, or total cholesterol
  • •12. Contraindications or hypersensitivity to the use of Quetiapine or related group of
  • •13. Class III heart failure with evidence of recent progression, or Class IV heart failure per NYHA functional classification system
  • •14. Uncontrolled and untreated hypertension
  • •15. Myocardial infarction or acute coronary syndrome within 6 months prior to
  • •16. Significant pre-existing gastrointestinal co-morbidities that would preclude
  • •compliance with oral medication.
  • •17. History of suicidal tendencies within the past 3 months prior to Screening or immediate risk of harm to self or other at the time of
  • •Screening, as judged by the investigator
  • •18. Uncontrolled and un-treated diabetes mellitus
  • •19. An unusual or abnormal diet, for whatever reason e.g. religious fasting
  • •20. Smoking¡Ý 9 cigarettes/beedies per day
  • •21. With bleeding disorders
  • •22. On treatment with alpha adrenergic receptor blocking agents
  • •23. Pregnant females as determined by positive serum or urine hCG test at Screening or prior to the first dose of study medication (Day 1)
  • •24. Lactating female
  • •25. On class 1A antiarrhythmics, class III antiarrhythmics, antipsychotics, antibiotics, other drugs associated with QT prolongation
  • •26. On drugs which are enzyme inducer or inhibitors of CYP450 3A4, 5, and 7.

研究者

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