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.

Phase 1

Completed

• Conditions: Refractory Epilepsy

• Registration Number: CTRI/2015/08/006138
• Lead Sponsor: Emcure Pharmaceuticals Ltd

Brief Summary

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

**Primary Objective:** The primary objective of this study is to compare the steady-statebioavailability of Emcure Pharmaceuticals’ felbamate tablets USP 600 mg withFelbatol® 600 mg tablets MEDA Pharmaceuticals after repeated administration inadult male and non-pregnant female epilepsy patients already established on felbamate monotherapy oradjunctive therapy under fastingcondition.

**SecondaryObjective:** Thesecondary objective of this study is to monitor the safety and tolerability ofmultiple doses of felbamate 600 mg tablets in adult male and non-pregnantfemale epilepsy patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-09
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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.
• Patients must provide written informed consent prior to any study related procedures being performed.
• Patients must have a willingness and ability to comply with the protocol requirements.
• Patients should be otherwise healthy as per investigator‟s discretion as determined by physical examination, medical history, and routine hematological and biochemical tests.
• 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.

Exclusion Criteria

• 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.
• Patients who are unable to fulfill study requirements in relation to conforming to the visit schedule.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Safety endpoints:	• Incidence and nature of adverse events

Trial Locations

Locations (4)

Grant Medical Foundation Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Mangala Hospital and Mangala kidney Foundation; 🇮🇳 Kannada, KARNATAKA, India

Medipoint Hospitals; 🇮🇳 Pune, MAHARASHTRA, India

Ratandeep Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Grant Medical Foundation Ruby Hall Clinic

🇮🇳Pune, MAHARASHTRA, India

Dr Santosh Sontakke

Principal investigator

020-66455100

info@rubyhall.com