FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2015/08/006138 [Registered on: 27/08/2015] Trial Registered Prospectively
Last Modified On: 14/04/2016
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study comparing felbamate tablets USP 600 mg of Emcure Pharmaceuticals Ltd., India to the Reference Listed Drug (RLD), Felbatol® (felbamate) 600 mg tablets manufactured by MEDA Pharmaceuticals Inc, USA in adult male and nonpregnant female epilepsy patients. 
Scientific Title of Study   A multi-centre, randomized, open label, multi-dose, two treatment, two-way crossover, steady state, bioequivalence study comparing felbamate tablets USP 600 mg of Emcure Pharmaceuticals Ltd., India to the Reference Listed Drug (RLD), Felbatol® (felbamate) 600 mg tablets manufactured by MEDA Pharmaceuticals Inc, USA in adult male and nonpregnant female epilepsy patients under fasting condition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MA-CT-15-002, Final version 1.0, Amendment 2.0, 10 Jul 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Shivashankar P 
Designation  Associate Manager- Medical Affairs and Phamacovigilance 
Affiliation  Manipal AcuNova Ltd., 
Address  Mobius Towers, SJR-i-Park, EPIP Whitefield, Bangalore-560 066, India.

Bangalore
KARNATAKA
560 066
India 
Phone  91-8066915700  
Fax  91-8066915719  
Email  shivashankar.p@ecronacunova.com  
 
Details of Contact Person
Public Query  
Name  Sudhir A Patel 
Designation  Senior Project Manager 
Affiliation  Manipal Acunova Limited 
Address  Mobius Towers, SJR i-Park, EPIP, Whitefield, Bangalore – 560 066, India.

Bangalore
KARNATAKA
560 066
India 
Phone  91-8066915751  
Fax  91-8066915719  
Email  sudhir.patel@ecronacunova.com  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Ltd Plot No P2 ITBT Park MIDC Phase II Hinjwadi Pune 411057 India 
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Ltd 
Address  Plot No P2 ITBT Park MIDC Phase II Hinjwadi Pune 411057 India Tel 91-20-39821300 Fax 91-20-39821340  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santosh Sontakke  Grant Medical Foundation Ruby Hall Clinic  40 Sassoon road Pune 411001 Maharashtra India
Pune
MAHARASHTRA 		 020-66455100
020-26164529
info@rubyhall.com 
Dr Shankara Nellikunja  Mangala Hospital and Mangala kidney Foundation  Vajra Hills Kadri Road Mangalore-575003 Karnataka State India
Dakshina Kannada
KARNATAKA 		 91-824-2443088
91-824-2444124
mangalahospital@rediffmail.com 
Dr Praveen Jain Harawat  Medipoint Hospitals  241/1, New D.P.Road, Aundh, Pune-411007, Maharashtra, India.
Pune
MAHARASHTRA 		 020-39841200
020-27298081
info@astermedipoint.com 
Dr Vaishal N Vora  Ratandeep Multispeciality Hospital  2nd Floor Nakshatra Complex Above HDFC Bank Maninagar Cross Roads Maninagar Ahmedabad-380008 Gujarat India
Ahmadabad
GUJARAT 		 079-25465119
079-22124022
ratandeepmsh@yahoo.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee Poona Medical Research Foundation  Approved 
Mangala Institutional Ethics Committee  Approved 
PENTA-MED ETHICS COMMITTEE  Approved 
Ratandeep Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Refractory Epilepsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Felbamate tablets USP 600 mg of Emcure Pharmaceuticals Ltd, administrated orally   Dose: 1800 mg to 3600 mg/day based on stabilization In three divided doses, for 2 to 6 weeks 
Comparator Agent  Felbatol® (felbamate) 600 mg tablet of MEDA Pharmaceuticals, administrated orally   Dose: 1800 to 3600 mg/day In three divided doses, for 2 to 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male and non-pregnant female patients aged between 18 – 65 years.
2.Patients diagnosed with epilepsy who do not respond adequately to alternative treatment and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable when treated with felbamate.
3. Patients must provide written informed consent prior to any study related procedures being performed.
4. Patients must have a willingness and ability to comply with the protocol requirements.
5. Patients should be otherwise healthy as per investigator‟s discretion as determined by physical examination, medical history, and routine hematological and biochemical tests.
6. Female patients of childbearing potential, in addition to having a negative serum pregnancy test, must be willing to use a reliable means of contraception (other than hormonal contraceptives) e.g. barrier method (diaphragm, condom, etc.), surgical sterilization or abstinence for the duration of the study. Hormonal contraceptives should be avoided within 2 month prior to study entry.
 
 
ExclusionCriteria 
Details  1.History of allergic reactions to felbamate and related drugs.
2.Concurrent psychiatric diagnosis
3.RBC, WBC and platelet counts below the lower limit of normal for the laboratory conducting the test and / or as per Investigator’s discretion
4.History of aplastic anemia or bone marrow suppression
5.Medical or surgical condition interfering with absorption, metabolism, or excretion of felbamate
6.Serum transaminases >2x the upper limit of normal or history or evidence of hepatic dysfunction
7.Concurrent use of drugs known to suppress bone marrow function
8.Expected change of concomitant medications during trial
9.History of alcohol dependence, alcohol abuse or drug abuse within the past 6 months. Recent or current alcohol abuse (more than 5 units per week, 1 unit equal to 10 mL or 8 gm of pure alcohol) or suspected abuse.
10.Compliance with outpatient medication schedule not expected.
11. Patients who are unable to fulfill study requirements in relation to conforming to the visit schedule. 
 
Method of Generating Random Sequence   Other 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the bioavailability of Emcure Pharmaceuticals’ felbamate relative to that of Felbatol   Blood samples for pharmacokinetic evaluations will be drawn within 15 minutes prior to the morning dose on days 1, 5, 6 and 7. On day 7, additional post-dose samples will be collected at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00 and 8.00 hours  
 
Secondary Outcome  
Outcome  TimePoints 
Safety endpoints:
• Incidence and nature of adverse events
• Incidence of drug related adverse events
• Clinically significant changes in the vital signs, physical and laboratory examination and ECG  		 Not Applicable 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   05/09/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study is a comparative randomized, open-label, two-treatment, two-way crossover, two-sequence, two period, steady-state bioequivalence trial with no washout between the two periods under fasting condition. A three to six week period of open-label felbamate therapy (Felbatol®) given alone or in combination with other antiepileptic therapy will precede day 1 of the pharmacokinetic portion of the study.

Primary Objective: The primary objective of this study is to compare the steady-state bioavailability of Emcure Pharmaceuticals’ felbamate tablets USP 600 mg with Felbatol® 600 mg tablets MEDA Pharmaceuticals after repeated administration in adult male and non-pregnant female epilepsy patients already established on felbamate monotherapy or adjunctive therapy under fasting condition.

Secondary Objective: The secondary objective of this study is to monitor the safety and tolerability of multiple doses of felbamate 600 mg tablets in adult male and non-pregnant female epilepsy patients.  
Close