Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting Condition

NCT01566487 | Completed Phase 1

• 1 other identifier: 353-09
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, multicentric experimental bioequivalence study.

Conditions

Healthy

Keywords

Bioequivalence; Quetiapine fumarate; crossover

Outcome Measures

Primary Outcomes (1)

• Area under curve(AUC)

  Period 1 - Pre-dose in day 3, 4 and 5 and period 2 pre dose in day8,9 and 10 and 0.25,0.5,0.75,1.25,1.5,1.75,2,2.5,3,4,6,8,10 & 12 hrs post-dose on day 5 and day 10

Study Arms (2)

Quetiapine fumarate tablets 300 mg

EXPERIMENTAL

Quetiapine fumarate film-coated tablets 300 mg of Dr. Reddy's Laboratories Limited

Drug: Quetiapine fumarate

Seroquel

ACTIVE COMPARATOR

Seroquel film-coated tablets 300 mg of Astrazeneca Pharmaceuticals, USA

Drug: Quetiapine fumarate

Interventions

Quetiapine fumarate DRUG

Quetiapine fumarate tablets 300mg

Also known as: Seroquel

Quetiapine fumarate tablets 300 mg; Seroquel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Schizophrenic patients, between 18 and 55 years of age (inclusive).
• 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
• Having a Body Mass Index (BMI) between 18 and 35 (inclusive). calculated as weight in kg/height in m2.
• 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).
• The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
• Able to comply with study procedures in the opinion of the investigator.
• In case of female patient the serum pregnancy test at screening visit must be negative.
• Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide. diaphragm with spermicide.Absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to Study drug administration\] sexual partner) for at least 4 weeks prior to study drug administration,during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. (It is investigator's responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient/LAR in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol).
• In case of Male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
• (It is investigator's responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient/LAR in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol).

You may not qualify if:

• Known hypersensitivity/allergy or idiosyncratic reaction to Quetiapine or its excipients.
• Clinically significant illnesses (including hypotensive episodes and systemic infection) or surgery within 4 weeks prior to the first dosing.
• 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.
• History of syncope or orthostatic hypotension
• 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 I0 days prior to and throughout the study.
• Alprazolam, Fluoxetin, Imipramine, Haloperidol, Risperidone. (Refer Appendix 4 for list of nonpermissible medication)
• A history of alcohol or drug dependence by DSM-IV criteria within 6 months prior to screening.
• Smokers who smoke 10 or more than 10 cigarette/day or inability to abstain from smoking during the study
• 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 equol to 200 mL; patient may be dosed 60 days after blood donation.
• A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
• Positive test for HIV infection.
• ECG abnormalities (clinically relevant), vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mnHg, diastolic blood pressure lower than 50 or over 90 mmHg or patient on any antihypertensive medication or heart rate less than 50 or over 100 bpm) or significant orthostatic hypotension (i.e.. a drop in systolic blood pressure of 30 mmHg or more and/or a drop in diastolic blood pressure of 20 mmHg or more on standing) at screening. Patients with vital signs values no more than 5% out of the specified range but considered stable could be included in the study at the discretion of the investigator.
• Any condition1 Abnormal baseline findings that in the investigator's judgement might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Lambda Therapeutic Research Ltd

Ahmedabad, Gujarat, 380 061, India

Location

MeSH Terms

Interventions

Quetiapine Fumarate

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr.Sachin Patkar, MD

  Masina hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: March 29, 2012
• Study Start: June 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 29, 2012

Record last verified: 2010-04

Locations

IN (1)