A Bioequivalence study to compare the Bioequivalence of two formulation of quetiapine in schizophrenic patients.
- Conditions
- Health Condition 1: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2010/091/000181
- Lead Sponsor
- Dr Reddys Laboratories Ltd India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
1.Written informed consent for participation in the study by the patient and Patient?s Legally Acceptable Representative (LAR). If the patient or his/her legally acceptable representative is unable to read/write ? an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form.
2.Patient has a documented clinical diagnosis of stable schizophrenia (DSM IV-TR) controlled by a stable 300 mg Quetiapine regimen given at 12-hour intervals from at least 2 weeks prior to the first dosing, as confirmed by Principal Investigator
3. Having a Body Mass Index (BMI) between 18 and 35 (inclusive), calculated as weight in kg / height in m2.
4. Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG recordings and Chest X ray (Postero-anterior view).
5.The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
6.Able to comply with study procedures in the opinion of the investigator
1.Known hypersensitivity/allergy or idiosyncratic reaction to Quetiapine or its excipients.
2.Clinically significant illnesses (including hypotensive episodes and systemic infection) or surgery within 4 weeks prior to the first dosing.
3.Current or relevant history of serious, severe or unstable psychiatric illness (Meeting the criteria for any other (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I) except schizophrenia.
4.History of syncope or orthostatic hypotension.
5.Ingestion of any medication other than listed below at any time in 10 days before the first study drug administration. In any such case Patient selection will be at the discretion of the Principal Investigator. Following is the list of permissible medications, provided, the patients are on a stable regimen at least 10 days prior to and throughout the study.
Alprazolam, Fluoxetin, Imipramine, Haloperidol, Resperidone. (Refer Appendix-I for list of nonpermissible medication)
6.A history of alcohol or drug dependence by DSM-IV criteria within 6 months prior to screening.
7.Smokers who smoke 10 or more than 10 cigarette/day or inability to abstain from smoking during the study.
8.Donation of blood (≥ 1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication or during the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the bioavailability and characterise the pharmacokinetic profile of the Sponsor?s formulation (Quetiapine film coated tablets 300 mg) with respect to the reference formulation (Seroquel® film coated tablets 300 mg) in adult Schizophrenic patients (stabilized on Quetiapine 600 mg per day) under fasting conditionsTimepoint: NI
- Secondary Outcome Measures
Name Time Method To monitor the safety of the patients who are exposed to the investigational medicinal product.Timepoint: NI