Health Condition 1: null- schizophrenia
Conditions
Interventions
Intervention1: Bioequivalence study on Quetiapine 300mg tablets in adult Schizophrenic patients: Quetiapinefumarate
300 mg twice daily for 5days in each period.
Multiple dose steady state Bioequivalen
Sponsors
GVK BIOSCIENCES PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the multiple-dose oral bioequivalence of Quetiapine fumarate Tablets 300 mg of AustarPharma USA and SEROQUEL® (quetiapine fumarate) 300 mg Tablets, distributed by AstraZeneca Pharmaceuticals LP, when administered twice daily in adult Schizophrenic patients already receiving Quetiapine in stable regimen at steady state.Timepoint: Bioequivalence will be concluded if the 90% CI for the ratio of the geometric LS means falls within the acceptance range of 80.00â??125.00% for ln-transformed pk parameters (Cmax)ss and (AUC0-tou)ss for Quetiapine. timepoints:On 05th and 10th Day after the morning dosing post dose samples will be collected at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00 and 12.00 hours after dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of study subjectsTimepoint: Clinical examination, Vitals signs, ECG recordings safety monitoring will be done as per protocol | — |
Countries
India
Contacts
Public ContactCh Nagaratnam MD
GVK BIOSCIENCES PVT LTD
Outcome results
None listed