Health Condition 1: null- Refractory Epilepsy
Conditions
Interventions
Intervention1: Felbamate Tablets 600 mg: Manufactured by: Lannett Company Inc., USA
Tab Felbamate 600 mg will be given in the PK phase, as one tablet thrice a day for 10 days in Period I and II (tota
Sponsors
Lannett Company Inc
Raptim Reserach
Eligibility
Inclusion criteria
Inclusion criteria: The patients who fulfill all the following inclusion criteria will be included: 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 for male volunteers and 18.0 to 27.9 Kg/m2 for female volunteerâ??s (both inclusive). 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 (blood pressure, pulse rate, respiratory rate and axillary temperature). v. Patients with normal/ not significant laboratory values as determined by hematological tests, biochemistry, urine analysis and ECG in correlation with clinical findings. vi. Willingness to follow the protocol requirement as evidenced by written informed consent. vii. Agreeing to, not using or conforming to not having used any medication (prescription and over the counter), including vitamins and minerals for 15 days prior to study & during the course of the study. viii. No history or presence of significant alcoholism. ix. No history of drug abuse. x. Non-smokers, ex-smokers and moderate smokers will be included. â??Moderate smokersâ?? are defined as those who smoke 10 cigarettes or less per day, â??Ex-smokersâ?? are those who stopped smoking for at least 3 months. xi. All female patients having negative serum pregnancy test prior to enrolling into the study. 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. Unacceptable methods include oral or implanted contraceptives.
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, prior to drug administration day other than Felbamate iii. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological (other than refractory epilepsy), metabolic hematological, gastrointestinal, endocrine or immunological. iv. At baseline (Prior to randomization): ï?§ Two-fold increase in the highest, 2-day pre-study seizure frequency ï?§ Single generalized, tonic-clonic seizure if none occurred during pre-treatment screening and/or ï?§ 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 malignancy or any other serious diseases. vii. Any contraindication to blood sampling. viii. Refusal to abstain from smoking or consumption of 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 and 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 and II tests, HBsAg or HCV tests. xii. Positive urine screen for drugs of abuse and breath alcohol test done during check-in process. xiii. Positive urine pregnancy test and serum pregnancy test for female patients done during screening and check-in process, respectively. xiv. A history of allergic or adverse reactions to Felbamate or any comparable or similar product. xv. A history of severe hepatic impairment, drug induced leukopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine clinical bioequivalence of Felbamate 600mg tablet of LANNETT Company, Inc., (Test) with that of an already marketed reference formulation i.e. Felbatol® 600 mg tablet of Meda Pharmaceuticals Inc.(Reference) in 38 adult epileptic (partial seizures with and without generalization) in patientsTimepoint: At the end of the Pharmacokinetic phase, that is, after completion of Period I and Period II. The PK analysis of the per protocol population will begin about 48 days (4 weeks - up-titration plus 20 days PK phase) after enrollment into the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety of administration of Felbamate Tablets 600 mg in refractory partial epilepsy patients stabilised on Felbamate.Timepoint: Safety monitoring will be conducted throughout the study. Safety analysis will be carried out in the intention to treat population at the end of the down-titration phase. | — |
Countries
India
Contacts
Public ContactDr Himali Gole
Raptim Research Ltd.
Outcome results
None listed