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CTRI Number  CTRI/2017/05/008506 [Registered on: 08/05/2017] Trial Registered Prospectively
Last Modified On: 26/05/2017
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study   Oral Suspension 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Steady - State Bioequivalence Study of Felbamate Oral suspension 600 mg/5 mL (Fasting) 
Scientific Title of Study   A multicenter, open label, multiple-dose, randomized, two-treatment, two period, two-sequence, two-way crossover, steady-state bioequivalence study of Felbamate Oral suspension 600 mg/5 mL of Getz Pharma Research Pvt. Ltd., India with that of FELBATOL® (Felbamate) Oral suspension 600 mg/5 mL of MEDA Pharmaceuticals Inc., Somerset, New Jersey, 08873-4120,USA.,in adult male and non-pregnant female epilepsy (partial seizures with and without generalization) patients already established (run-in) on Felbamate as an monotherapy/adjunctive therapy under fasting condition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C14215 Version No : 02 Date 30 Mar 2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chakravarthy K MBBS MD 
Designation  CROs Medical Expert 
Affiliation  Aizant Drug Research Solutions Pvt. Ltd., 
Address  Aizant Drug Research Solutions Pvt Ltd Survey No 172 173 Apparel Park Road Dulapally Village Quthbullapur Mandal Hyderabad Survey No 172 173 Apparel Park Road Dulapally Village Quthbullapur Mandal

Rangareddi
ANDHRA PRADESH
500100
India 
Phone  040-23792190  
Fax  040-23792223  
Email  Chakravarthy.k@aizant.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chakravarthy K MBBS MD 
Designation  CROs Medical Expert 
Affiliation  Aizant Drug Research Solutions Pvt. Ltd., 
Address  Aizant Drug Research Solutions Pvt Ltd Survey No 172 173 Apparel Park Road Dulapally Village Quthbullapur Mandal Hyderabad Survey No 172 173 Apparel Park Road Dulapally Village Quthbullapur Mandal

Rangareddi
ANDHRA PRADESH
500100
India 
Phone  040-23792190  
Fax  040-23792223  
Email  Chakravarthy.k@aizant.com  
 
Details of Contact Person
Public Query  
Name  Dr Venkatesh Pandiri MBBS 
Designation  CROs Medical Officer 
Affiliation  Aizant Drug Research Solutions Pvt. Ltd., 
Address  Aizant Drug Research Solutions Pvt Ltd Survey No 172 173 Apparel Park Road Dulapally Village Quthbullapur Mandal Hyderabad Survey No 172 173 Apparel Park Road Dulapally Village Quthbullapur Mandal

Rangareddi
ANDHRA PRADESH
500100
India 
Phone  040-23792190  
Fax  040-23792223  
Email  venkatesh.pandiri@aizant.com  
 
Source of Monetary or Material Support  
Getz Pharma Research Pvt. Ltd. Plot # PL-11, Anand Nagar M.I.D.C. Addl. Ambernath, Ambernath (East), Dist. Thane-421 506, Maharashtra, India 
 
Primary Sponsor  
Name  Getz Pharma Research Pvt Ltd 
Address  Getz Pharma Research Pvt. Ltd. Plot # PL-11, Anand Nagar M.I.D.C. Addl. Ambernath, Ambernath (East), Dist. Thane-421 506, Maharashtra, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikram Sharma   St. Theresas Hospital   Neurology Dept, First Floor. Sanathnagar, Hyderabad-500018. Rangareddi ANDHRA PRADESH
Rangareddi
ANDHRA PRADESH 		 9866960555
04023814556
drvikramsharma@gmail.com 
Dr Neehar Potluri  Surakshaka Diabetic Centre (P) LTD.,  MIG-218, KPHB Main Road, Kukatpally, Hyderabad-500 072, Telangana State, India.
Rangareddi
ANDHRA PRADESH 		 9246207969

neeharpotluri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Continental Hospitals  Submittted/Under Review 
ST. THERESAS HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  adult male and non-pregnant female epilepsy patients already established (run-in) on Felbamate as an monotherapy/adjunctive therapy under fasting condition.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Felbamate Oral suspension 600 mg/5 mL  To determine the steady state bioequivalence of Felbamate Oral suspension 600 mg/5 mL  
Comparator Agent  FELBATOL® (Felbamate) Oral suspension 600 mg/5 mL of MEDA Pharmaceuticals Inc  To determine the steady state bioequivalence of Felbamate Oral suspension 600 mg/5 mL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  The patients who fulfill all the following inclusion criteria will be included:
i. Patients should be in the range of 18 - 45 years of age (both inclusive).
ii. BMI should be in the range of 18.5 to 24.9 kg/m2
iii. Patients having refractory partial seizures with and without generalization not controlled on standard antiepileptic drugs at therapeutic levels.
iv. Patients with normal findings as determined by baseline history, physical examination and vital signs (seated blood pressure, radial pulse rate, respiratory rate and axillary temperature).
v. Patients with normal / not significant laboratory values as determined by hematological tests, biochemistry, urine analysis, ECG and chest X-ray (P/A view) in correlation with clinical findings.
vi. Willingness to follow the protocol requirement as evidenced by voluntary written informed consent.
vii. Agreeing to, not using or conforming to not having any medication (prescription and over the counter, herbal products), including vitamins and minerals for 15 days prior to study & during the course of the study except any one of Valproic acid, Gabapentin, Levetiracetam or Pregabalin for ongoing therapy of their illness.
viii. No history or presence of significant alcoholism (> 3 units of alcohol per day) within one year prior to drug administration.
ix. No history of smoking and of drug abuse.
x. All female patients who are of child bearing potential or those within the first two years of the onset of menopausal syndrome using acceptable methods of birth control at least 30 days prior to onset of screening period and till 30 days post last dose of study drug in period-II. Acceptable birth control methods include Barrier methods such as diaphragm/condom with spermicide, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence. Unacceptable methods include oral or implanted or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study patient).
 
 
ExclusionCriteria 
Details  The patients meeting with any one of the following criteria should be excluded:
i. History of aplastic anemia or hepatic failure.
ii. Requiring medication for any ailment having enzyme-modifying activity in previous one month other than Felbamate, Valproic acid, Gabapentin, Levetiracetam or Pregabalin prior to drug administration day and during the course of the study.
iii. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological (other than refractory epilepsy), metabolic hematological, gastrointestinal, endocrine or immunological illness.
iv. Participation in any other clinical study within 90 days prior to onset of screening period.
v. History of or currently active malignancy or any other serious diseases.
vi. Any contraindication to blood sampling.
vii. Blood donation within 90 days prior to the commencement of the study.
viii. Patients with positive HIV I/II, HCV tests.
ix. Patients with Positive HBsAg, Positive anti-Hbc and Positive anti HBs.
x. For female patients: Positive serum pregnancy test for female patients.
xi. A history of allergic or adverse reactions to Felbamate, its formulation excipients or any comparable or similar product (carbamates).
xii. A history of severe hepatic impairment, drug induced leucopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
xiii. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson’s disease.
xiv. Complete blood counts below accepted normal values.
xv. Elevation in liver enzymes, above the normal limits.
xvi. A history of or currently active granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic).
xvii. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Felbamate.
xviii. Concurrent use of other drugs known to suppress bone marrow function or causes a significant risk of drug induced hepatitis.
xix. Expected changes in concomitant medications during the period of study.
xx. A history of alcohol or drug dependence by Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria during the 6-month period immediately prior to study entry.
xxi. Not complied with outpatient medication schedule.
xxii. History of multiple syncopal episodes.
xxiii. Lactating or nursing or pregnant female patients or planning to become pregnant during the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the steady state bioequivalence of Felbamate Oral suspension 600 mg/5 mL of Getz Pharma Research Pvt. Ltd., India with Standard Reference - FELBATOL® (Felbamate) Oral suspension 600 mg/5 mL of MEDA Pharmaceuticals Inc., Somerset, New Jersey, 08873-4120, USA  To determine the steady state bioequivalence of Felbamate Oral suspension 600 mg/5 mL of Getz Pharma Research Pvt. Ltd., India with Standard Reference - FELBATOL® (Felbamate) Oral suspension 600 mg/5 mL of MEDA Pharmaceuticals Inc., Somerset, New Jersey, 08873-4120, USA 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of repeated doses of Felbamate Oral suspension 600 mg/5 mL in refractory partial epilepsy patients stabilized on Felbamate.  2 months clinical schedule 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

As per the randomized study code, patients will be instructed to take either test product  or reference product (suspension) 600 mg/5 mL (three times daily at 8.00 hours interval i.e. morning, afternoon and evening dose) orally, for the first seven days (days: 1-7 for Period-I and 11-17 for Period-II) in each study period.

During hospitalization, patients will be fasted for at least 10.00 hours prior to morning dose on day 8, day 9, day 10 in Period-I and day 18, day 19, day 20 in Period-II, respectively.

Patients will be administered stabilized treatment of Felbamate Oral suspension 600 mg/5 mL thrice a day (either test product or reference product) as per their randomization study code and stable down titrated dose of antiepileptic drug with 240 ±2 mL of water. 

Drinking water will not be allowed 1.00 hour before and after morning drug administration on  day 8, day 9, day 10 (Period-I) and on day 18, day 19, day 20 (Period-II) except for 240 ±2 mL of water administered during dosing. At all other times drinking water will be provided ad-libitum.

Patient will remain in sitting posture for 2 hrs post morning doses on day 8, day 9, day 10 during Period-I and day 18, day 19, day 20 during Period-II.

Drug administration will be ensured by the dosing personnel that the suspension is completely swallowed by the patient with a thorough check of the oral cavity using a flash light immediately after drug administration. Patients will be instructed to consume it whole with specified quantity of water. The dose will be administered in a staggered manner to maintain subsequent blood collection schedule. Record of drug administration for individual patient will be maintained in source document and Case Report Form.

Administration Procedure:

Subject will receive 600mg/ 5 mL of oral suspension with 60 mL of water (to assure complete consumption of dosage) on the day of dosing as per the randomization schedule and remaining volume 180mL (240-60=180mL) of water will be used for rinsing the syringe. After rinsing, subject will be instructed to drink remaining 180 mL of water with swirling.

Administration Procedure during Out-patient:
Subjects are instructed to consume 600mg/5ml of suspension with the help of graded cap provided with reference or test product. After consuming the specified quantity subjects are advised to rinse the graded cap with water and allowed to swallow to ensure total consumption of medication.  
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