CTRI/2015/08/006138
Completed
Phase 1
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.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Refractory Epilepsy
- Sponsor
- Emcure Pharmaceuticals Ltd
- Enrollment
- 28
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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