Study to prove bioequivalence of Risperidone prolonged-release susp. for Intra Muscular inj 25 mg/vial of Pharmathen S.A. Greece in adult schizophrenic patients who are on stable dose.
- Conditions
- Health Condition 1: null- Schizophrenia
- Registration Number
- CTRI/2018/01/011521
- Lead Sponsor
- Pharmathen S A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Adults (both inclusive) having clinical diagnosis of schizophrenia (as per DSM IV-TR or later).
2.Have body mass index of 18.5 to 30kg/m2.
3.Schizophrenic patients who are already receiving risperidone prolonged-release suspension for intramuscular injection 25 mg/vial every two weeks and who have received at least 3 doses of the same.
4.Adequate hematological parameters at screening defined by:
Total white blood cell count more than and equal to 4000/c.mm
ANC more than equal to 1500/mm3
Platelet count more than and equalto 75000/mm3
HB more than and equal to 9.0 gm/dl
5.Adequate hepatic function at screening as defined by:
Bilirubin less than and equal to 1.5 X ULN (upper limit of normal)
AST/ ALT less than and equal to 5 X ULN
6.Adequate renal function at screening as defined by S. creatinine less than and equal to 1.5 X ULN or creatinine clearance more than equal to 60ml/min.
7.Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or amenorrhoea for at least 12 consecutive months, must agree to 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 sexual partner) from screening, during the study and till the study completion (i.e. post study safety assessment after last PK sample collection in period II).
And Sexually active women must have a negative pregnancy test (at screening, before check-in on day 0) as well as must be non-lactating at the time of screening.
8.Willing and able to comply with housing, restrictions and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.
9.Patients should be otherwise healthy (except for the indication for which the antipsychotic treatment is given) as determined by physical examination, medical history and routine laboratory assessments.
1.A history of allergic reactions / hypersensitivity to risperidone or other excipients of study drug.
2.Subject with history of hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period.
3.Concurrent primary psychiatric (other than schizophrenia) or neurological diagnosis, including neurologic malignant syndrome, organic mental disorder, severe tardive dyskinesia, Parkinsonâ??s disease, history or presence of epilepsy or risk for seizures or other conditions that potentially lower the seizure threshold, history of cerebrovascular disease.
4.Subject who is having :
Clinically significant cardiac disorders (e.g. myocarditis, cardiomyopathy, bradycardia) or QTc > 500 milliseconds or Uncontrolled hypertension, unstable angina, recent history of myocardial infraction.
Myeloproliferative disorders (drug-induced or idiopathic).
Significant orthostatic hypotension at screening or before checkin on day 0; orthostatic hypotension will be considered when there is drop in systolic blood pressure of 30 mm Hg or more or diastolic blood pressure of 20 mm Hg or more on standing from supine measurements.
Presence of uncontrolled metabolic disorders including diabetes mellitus(HbA1c morethan 8 %).
Significant hyperprolactinaemia or with possible prolactin-dependent tumours.
History/presence of venous thromboembolism.
5.Expected changes in concomitant medications during the period of study.
6.Positive urine drug scan test (for drugs) or alcohol breath test (for alcohol abuse) at screening or baseline.
7.Patients who are on active treatment with drugs that are known to interact with risperidone (such as Strong CYP2D6 inhibitors,CYP3A4 and/or P-gp inhibitors or inducers, drugs known to prolong the QT interval; detailed list is provided in Annexure III).
Note: If the patient was on any of these drugs, sufficient wash out period (of at least 5 half-lives) must have elapsed since the last dose of such drug before the first dose of investigational medicinal product for the current study.
8.A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of risperidone.
9.Patients undergone major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
10.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
11.Chronic Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
12.History of difficulty with donating blood or difficulty in accessibility of veins.
13.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
14.Participation in any other clinical study and 5 half lives of the previous IMP has not elapsed since receipt of the last dose of previous IMP receipt at screening.
15.An unusual or abnormal diet, for whatever reason planned e.g. religious fasting during the course of the study.
16.Any condition/ abnormal baseline findings that in the Investigatorsâ?? 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. low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the bioequivalence at steady-state of Risperidone prolonged-release suspension for intramuscular injection 25 mg/vial of Pharmathen S.A., Greece in comparison with RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release suspension for intramuscular injection Manufactured by: Janssen Pharmaceutica N.V., Beerse, Belgium in adult schizophrenic patients who are already receiving Risperidone prolonged-release suspension for intramuscular injection 25 mg/vial.Timepoint: A total 47 blood samples will be collected. The pre dose blood sample will be collected within 5 min before dose1,2,3,4. After dose 4 administration in each period, the post-dose samples will be drawn at 4hr (d0),8hr(d0),24hrs(d1),36hr(d1),48hr(d2),72hr(d3),96hr(d4),120hr(d5),144hr(d6),156hr(d6),168hr(d7),180hr(d7),192hr(d8),204hr(d8),216hr(D9),240hr(d10),264 hr(d11),288hr (d12),312hr(d13),336hr(D14)following dose 4 drug administration in each period.
- Secondary Outcome Measures
Name Time Method To monitor safety and tolerability profile of the study formulation.Timepoint: NA