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: Health Condition 1: null- Refractory Epilepsy

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

1.Male and non-pregnant female patients aged between 18 â?? 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 investigatorâ??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.

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 Investigatorâ??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.

Study & Design

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