A study to evaluate the bioequivalence of Quetiapine with Seroquel in adult schizophrenic patients.
- Conditions
- Health Condition 1: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2010/091/000001
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
1.Written informed consent for participation in the study by the patient and Patient?s Legally Authorized Representative (LAR).
2.Schizophrenic patients, between 18 and 60years of age (inclusive).
3.Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR) on a stable dose of Quetiapine 600 mg per day for at least 10 days prior to screening.
4.Having a Body Mass Index (BMI) between 18 and 30 (inclusive), calculated as weight in kg / height in m2.
5.Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.
6.The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
7.Able to comply with study procedures in the opinion of the investigator.
8.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 1 and day 5 (before dosing) must be negative.
1.Known hypersensitivity or idiosyncratic reaction to Quetiapine and its excipients.
2.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.
3.Presence of Postural Hypotension (Defined as systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing up).
4.History of syncope or orthostatic hypotension.
5.Smokers who smoke 10 or more than 10 cigarette/day or inability to abstain from smoking during the study.
6.The presence of clinically significant abnormal laboratory values during screening.
7.Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication or during the study.
Note: In case the blood loss is less than or equal to 200 mL; Patient may be dosed 60 days after blood donation.
8.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV IgM antibodies.
9.Known case of HIV infection.
10.Supine blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beats per minute at screening.
11.Presence of cataract on Opthalmoscopic examination (slit lamp exam).
12.History of seizures.
13.History of agranulocytosis.
14.Patients having Hypertension or on any antihypertensive medication.
15.Patients with Diabetes mellitus or fasting blood glucose ≥ 126 mg/dl at screening visit.
16.Patients with abnormal thyroid function test at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
17.Patient with hyperprolactinemia at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
18.Dementia related psychosis.
19.Pregnant or lactating females.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary PK Parameters: Cmax,ss and AUC,ssTimepoint: NI
- Secondary Outcome Measures
Name Time Method Secondary PK Parameters: Cmin,ss, Tmax, PTF and Css,avTimepoint: NI