CTRI/2017/09/009657已完成未知
A Multicentric Open Label Randomized Two-Treatment Two-sequence Two-period Cross-over Steady state Clinical Study of Quetiapine 400 mg prolonged release tablets of Krka d d Slovenia EU Test with Seroquel Prolong 400 mg prolonged release tablets quetiapine of AstraZeneca GmbH Germany EU Reference in Adult Schizophrenic Patients Under Fed Conditions - Quetiapine in Adult Schizophrenic Patients
Krka d d Slovenia0 个研究点目标入组 52 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
- 52
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
- •Inclusion criteria
- •1.Adult schizophrenic patients with body mass index (BMI) between 18 to 30 kg/m2 and aged between 18 to 60 years (both inclusive) who are already receiving quetiapine 400 mg as SR/PR tablet formulation per day.
- •2.Patient is on for quetiapine 400 mg as SR/PR tablet formulation therapy and has been taking a stable dose of Quetiapine 400 mg as SR/PR tablet formulation per day for at least one month before enrolment in the study.
- •3.Patient should be on quetiapine 400 mg SR/PR therapy only.
- •4.Patient confirmed with Schizophrenia by a psychiatrist according to the Diagnostic and Statistical Manual V (DSM V) criteria.
- •5.Patient provided informed consent prior to inclusion in the study also witnessed and signed by a legally acceptable representative.
- •6.Patient should have no clinically significant abnormality in any of the laboratory parameters including ECG and Chest X-ray (P/A view) as per the discretion of Principal Investigator.
- •7. Patient having adequate hematologic reserve at screening as per principal investigator assessment.
- •8.Patient having adequate and stable hepatic function and renal, hematopoietic, cardiac and respiratory function at screening as per principal investigator assessment.
- •9.Patient is nonsmoker and nonalcoholic.
- •10.Female patient of childbearing potential must be willing to use a reliable method of birth control as directed by study physician.
- •11.Female patient of childbearing potential must have a negative serum pregnancy test at screening.
- •12.Patient is able to communicate and cooperate with the Investigator and his staff.
排除标准
- •Exclusion Criteria:
- •1.Patient had history of suicidal tendencies (e.g. suicidal attempts) 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.
- •2.Absolute neutrophil count <= 2000 /mm3 or /μL and WBC count <= 4000/mm3 or /μL.
- •3.Patient with seated systolic blood pressure lower than 110 or above 140 mm of Hg, diastolic blood pressure lower than 60 or above 90 mm of Hg and seated heart rate less than 60 or above100 beats per minute at screening.
- •4.Patient has concurrent neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, cerebrovascular disease, idiopathic Parkinsonâ??s disease or Alzheimerâ??s dementia.
- •5.Patient with history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic.
- •6.Patient who is pregnant or lactating.
- •7.Patient found to positive for HIV/HCV/ HBsAg.
- •8.Patient participation in a clinical drug study or bioequivalence study / Patient donated blood/had blood loss ( >150ml) within 90 days prior to study participation.
- •9.Patient had history of multiple syncopal episodes.
- •10.Patient known to have significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30mm Hg or more and/or a drop in diastolic blood pressure of 20mm Hg or more on standing).
- •11.Patient had history of drug abuse or dependence within 3 months prior to Screening.
- •12.Patient is having contraindications or hypersensitivity to the use of Quetiapine and any of the excipients of the study drugs or related group of drugs.
- •13.QTc prolongation >450 milliseconds for men and >470 milliseconds for women.
- •14.Patient had Class III heart failure with evidence of recent progression (worsening dyspnea, etc), or Class IV heart failure per NYHA functional classification system.
- •15.Patient had uncontrolled and untreated hypertension and /or Diabetes.
- •16.Patients using medication for Hypertension and/or Diabetes.
- •17.Patient had myocardial infarction or acute coronary syndrome within 6 months prior to screening.
- •18.Patient had significant pre-existing gastrointestinal co-morbidities that would preclude compliance with oral medication (e.g. chronic diarrhea, inflammatory bowel diseases, constipation).
- •19.Patient had bleeding disorders and is on anticoagulant therapy.
- •20.Patient on treatment with alpha adrenergic receptor blocking agents (Prazosin, Terazosin, Doxazosin).
- •21.Patient is unable to communicate with the investigator.
- •22.Patient consumed grape fruit (mosumbi/sweet lime) juice within the 48 hours prior to study check-in.
- •23.Patient had history of difficulty with donating blood or difficulty in accessibility of veins or difficulty in swallowing the tablet.
- •24.Patient with history of seizures.
- •25.Patient with risk factors for venous thromboembolism.
- •26.Patient with risk factors for pancreatitis
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