CTRI/2014/03/004510招募中未知
A randomized, open label, multicenter, balanced, two-treatment, two-sequence, two-period, multiple-dose, crossover, pivotal, oral bioequivalence study of Quetiapine fumarate Tablets 300 mg of AustarPharma, LLC, 18 Mayfield Ave, Edison, NJ 08837 USA and SEROQUEL® (quetiapine fumarate) 300 mg Tablets, distributed by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 when administered twice daily in adult Schizophrenic patients already receiving Quetiapine in stable regimen at steady state. - BESQ
GVK BIOSCIENCES PVT LTD0 个研究点目标入组 54 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 54
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.Physically healthy male and female Schizophrenic patients of and above 18 years of age as certified by physician.
- •2.Confirmed diagnosed patient of Schizophrenia as defined by DSM-IV criteria.
- •3.Subjects with a BMI between 18.5 to 24.9 Kg/m2 (including both).
- •4.Subjects with clinically acceptable physical health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests mentioned in Table below.
- •5.Subjects having normal 12-lead electrocardiogram (ECG) as certified by physician.
- •6.Subjects having normal chest X-Ray (P/A view).
- •7.Schizophrenic patients (DSM-IV criteria) already receiving quetiapine in a stable regimen at least for 4 weeks prior to screening.
- •8.Subjects able to communicate effectively.
- •9.Subjects willing to give written informed consent along with legally acceptable representative (where applicable) willing to give the consent and adhere to all the requirements of this protocol.
- •10.Female subjects who are
- •-postmenopausal or
- •-surgically sterile or
- •-practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence
排除标准
- •1.Subjects having contraindications or hypersensitivity to Quetiapine or related group of drugs.
- •2.History or presence of significant cardiovascular, pulmonary, hepatic, renal, endocrine, immunological, dermatological, neurological disease or disorder.
- •3.Subjects having clinically significant gastrointestinal pathology.
- •4.Subjects having Total Blood cell count below 4000/cmm, Absolute Neutrophil count below 2000/cmm
- •5.History or presence of significant alcoholism or drug abuse in the past one year.
- •6.History or presence of significant smoking (more than 10 cigarettes or bidis/Day or consumption of tobacco products).
- •7.Difficulty with donating blood.
- •8.Difficulty in swallowing solids like tablets or capsules.
- •9.Subjects having Systolic Blood Pressure >= 140 mm Hg.
- •10.Subjects having Diastolic Blood Pressure >= 90 mm Hg.
- •11.Patient prone to postural hypotension - Drop in Systolic Pressure by 30 mm of Hg or Diastolic pressure by 20 mm of Hg with change in posture.
- •12.Subjects with QTc 450 ms in screening ECG.
- •13.A depot neuroleptic drugs within 3 months prior to administration of study medication.
- •14.Use of any of the following cytochrome P450 3A4 inhibitors in the 14 Days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir.
- •15.Use of any of the following significant cytochrome P450 inducers in the 14 Days preceding enrolment, including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. Johns Wort, and glucocorticoids.
- •16.Patients who are currently receiving: monoamine oxidase inhibitors, tricyclic antidepressants, oral neuroleptics (other than Quetiapine, Lithium carbonate, Risperidone and Haloperidol), or type 1C anti-arrhythmics within two weeks of screening; herbal psychoactive treatments (St. Johns Wort, Kava Kava, Gingko Biloba) from at least 14 Days preceding enrolment.
- •17.Major illness during 3 months before screening.
- •18.Participation in a drug research study within past 3 months.
- •19.Donation of blood in the past 3 months before screening.
- •20.Female subjects demonstrating a positive pregnancy screen.
- •21.Female subjects who are currently breast-feeding.
- •22.Female subjects with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).
- •23.Presence of neurological disorders, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease.
- •24.History of granulocytopenia or myloproliferative disorder (drug induced or idiopathic)
- •25.History of epilepsy or risk of seizures
- •26.History of multiple syncopal attacks
研究者
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