A clinical trial to study comparative bioavailability of Quetiapine fumarate Tablets 300 mg in adult Schizophrenic patients already receiving Quetiapine
- Conditions
- Health Condition 1: null- schizophrenia
- Registration Number
- CTRI/2014/03/004510
- Lead Sponsor
- GVK BIOSCIENCES PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 54
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
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method