Health Condition 1: null- adult male and non-pregnant female epilepsy patients already established (run-in) on Felbamate as an monotherapy/adjunctive therapy under fasting condition
Conditions
Interventions
Intervention1: Felbamate Tablets 600 mg Oral Tablets: Patients will be titrated upwards with Felbamate (reference product) starting with 600mg OD with increments up to 600mg Q8h.
The total study durat
Sponsors
Getz Pharma Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 any of their illnesses. 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)
Exclusion criteria
Exclusion criteria: 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. At baseline (Prior to randomization): • Two-fold increase in the highest, 2-day pre-study seizure frequency; • Single generalized, tonic-clonic seizure if none occurred during pre-treatment screening and/or; • Significant prolongation of generalized, tonic-clonic seizures and Status Epilepticus. v. Participation in any other clinical study within 90 days prior to onset of screening period. vi. History of or currently active malignancy or any other serious diseases. vii. Any contraindication to blood sampling. viii. Refusal to abstain from smoking or consumption of alcohol and tobacco products 72.00 hours before morning drug administration on days- 10 and 20 and until after the last blood sample collection in each study period. ix. Use of xanthine containing food or beverages (chocolates, tea, coffee or cola drinks), grapefruit juice or products containing grapefruit and alcohol or any alcoholic products, for 72.00 hours before morning drug administration on days- 10 and 20 and until after the last blood sample collection in each study period. x. Blood donation within 90 days prior to the commencement of the study. xi. Patients with positive HIV I/II, HBsAg or HCV tests. xii. Patients with positive HBsAg, positive anti-Hbc and positive anti HBs. xiii. Positive urine screen for drugs of abuse and breath alcohol test done during check-in process. xiv. For female patients: Positive serum pregnancy test for female patients during screening and enrolment/check-in process. xv. A history of allergic or adverse reactions to Felbamate, its formulation excipients or any comparable or similar product (carbamates). xvi. A history of severe hepatic impairment, drug induced leucopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease xvii. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease. xviii. Complete blood counts below accepted normal values. xix. Elevation in liver enzymes, above the normal limits. A history of or currently active granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic). xx. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Felbamate. xxi. Concurrent use of other drugs known to suppress bone marrow function or causes a significant risk of drug induced hepatitis. xxii. Expected changes in concomitant medications during the period of study. xxiii. 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. xxiv.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the steady state bioequivalence of Felbamate Tablets 600 mg of Getz Pharma Research Pvt. Ltd., India, with Standard Reference - FELBATOL® 600 mg of MEDA Pharmaceuticals Inc., Somerset, New Jersey, 08873-4120, USA, in 32 adult epileptic (partial seizures with and without generalization) patientsTimepoint: 2 Months Clinical Schedule | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of repeated doses of Felbamate 600 mg tablets in refractory partial epilepsy patients stabilized on Felbamate.Timepoint: 2 Months Clinical Schedule | — |
Countries
India
Contacts
Public ContactDr Venkatesh MBBS
Aizant Drug Research Solutions Pvt. Ltd.,
Outcome results
None listed