A clinical trial to study Bioequivalence of two formulations of Quetiapine fumarate in Adult Patients suffering from schizophrenia.

Completed

• Conditions: Schizophrenia

• Registration Number: CTRI/2010/091/006114
• Lead Sponsor: Ipca Laboratories Limited

Brief Summary

This is a Randomized, Open Label, Balanced, Multicentre, Two-Treatment, Two-Period, Two-Sequence, Steady state, Multiple dose, Crossover, Bioequivalence Study of Two formulations of Quetiapine fumarate tablet 300 mg in Adult Patients suffering from schizophrenia. It is expected that sponsors test formulation will show pharmacokinetics similar to that of the reference listed drug and will prove bioequivalent to the reference drug. The trial will be conducted in Indian patients only and within India only. First patient was enrolled in the study on April 20, 2011.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-20
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR) on a stable dose of quetiapine 300 mg twice a day for at least 14 days prior to screening 2.
• Females and/or males patients aged 18 to 55 years (both inclusive) 3.
• Patients having a Body Mass Index (BMI) between 18 kg/m2 and 35 kg/m2 (both inclusive) 4.
• Patient and/or his/ her Legally Acceptable Representative are willing to give written informed consent for participation in the trial 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 (PA view if required) recordings.
• The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
• Women of child-bearing potential and all men must agree to use a medically accepted method of contraception from screening, while receiving protocol-specified medication till end of study.
• Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (e.g., hysterectomy or tubal ligation).
• Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study; 8.
• Female patients of childbearing potential must have a negative serum pregnancy test (beta-HCG) at Screening.

Exclusion Criteria

• Known hypersensitivity or idiosyncratic reaction to quetiapine or lack of response to quetiapine fumarate as judged by the investigator2.
• Current or relevant history of serious, severe or unstable psychiatric illness, meeting the criteria for any other (DSM-IV Axis I) except schizophrenia.3. History of syncope or orthostatic hypotension or 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.
• Any condition/ Abnormal baseline findings that in the investigators?
• judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study e.g. Abnormality in vital signs (systolic blood pressure <90 or >140mmHg or diastolic blood pressure <50 or >90 mmHg or heart rate <50 beats/min or >100 beats/min at screening, randomisation and at pre-dose vital signs).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, Trifluperazine, Sertraline and centrally acting anticholinergic drugs.6. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.7. Pregnancy or lactation8.
• 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 saquinavir9.
• Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids10.
• Substance abuse or alcohol dependence at enrollment (except dependence in full remission), as defined by DSM-IV criteria11.
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment12.
• Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator13.
• History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery14.
• Concomitant treatment with other psychotropic drugs (e.g. antidepressive agents, anticonvulsants, other neuroleptics such as Citalopram, Fluvoxamine, Oxcarbazepine, Clonazepam, Escitaopram, and Divalproex Sodium) except benzodiazepines or hypnotics15.
• Patient reactive to HIV, HBSAg & Hepatitis C16.
• History of seizure disorder17.
• Hospitalisation for schizophrenia within 1 month before entering into the study18.
• Previous treatment with any other study medication within the last 4 weeks prior to enrollment into this study.
• A patient known to have Diabetes Mellitus (DM) 21.
• Donated blood within 90 days before enrollment in the study.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize the Pharmacokinetic profile of test formulation relative to that of the reference and to assess their Bioequivalence.	Multiple time points up to 12 hours on last day of each period (i.e. Day 05 and Day 10).

Secondary Outcome Measures

Name	Time	Method
To monitor the safety and tolerability of two formulations	During the study period.

Trial Locations

Locations (5)

108 - Rajvee Towers,; 🇮🇳 Padra, India

Aastha Psychiatric Nursing Home Deaddiction Centre and Sex Therapy Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Anand Hospital; 🇮🇳 Gandhinagar, GUJARAT, India

Riddhi Hospital; 🇮🇳 Course,, India

Shivmm Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

108 - Rajvee Towers,

🇮🇳Padra, India

Dr. Ismail Pala

Principal investigator

919825257004

dripala@gmail.com