Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes
Conditions
Interventions
Intervention1: Felbamate Tablets 600mg of Lannett Company Inc., USA: As per randomization schedule, subjects will be instructed to receive Test or Reference products of one tablet of Felbamate 600mg t
Sponsors
Lannett Company Inc
Eligibility
Inclusion criteria
Inclusion criteria: A patient fulfilling all the following criteria will be included in the present study: 1) Patients willing to provide written informed consent for participation in the study; 2) Having ability to comprehend the nature and purpose of the study; 3) Willing to be available for the entire study period and to comply with protocol requirements. 4) Disease population and treatment condition â?? Subjects with documented clinical diagnosis of refractory partial seizures with or without generalization.Subjects with partial seizures with or without generalization not controlled with any of standard antiepileptic regimen of Sodium Valproate (or Valproic acid), Levetiracetam, Gabapentin or Pregabalin at therapeutic levels; 5) BMI in the range of 18.5 to 29.99 kg/m2 both inclusive. 6) Non-smoker or ex-smoker or mild / moderate smokers and willing to abstain from chewing or smoking any tobacco containing product at least 72.00 hrs prior to first dosing (onset of up-titration) of the study and throughout study. 7) Willing to abstain from alcohol or alcoholic products within 24.00 hrs prior to first dosing (onset of up-titration) of the study and throughout the study. 8) Willing to abstain from, xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) within 72.00 hrs prior to first prior to first sample collection in each study period and throughout the sampling points. 9) Willing to abstain from grapefruit or its juice within 72.00 hrs prior to first prior to first sample collection in each study period and throughout the sampling points. 10) Clinically non-significant serum electrolytes (sodium, potassium and chloride). 11) With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests, urine analysis. 12) With a normal or clinically non-significant 12-lead ECG. 13) In case of female subjects: • Negative urine pregnancy test during screening and, negative serum β-HCG test at baseline visits and at check-in for housing during each study period. • Patients with child bearing potential or those within their first two years of onset of menopausal syndrome must either abstain from sexual intercourse, or must be using acceptable methods of birth control during the study (Acceptable birth control methods include barrier methods such as diaphragm/condom with spermicide or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed), but must not use hormonal contraceptive (either oral/implants)).
Exclusion criteria
Exclusion criteria: A patient fulfilling any one of the following criteria will be excluded from the study: 1) Institutionalized patients. 2) A history of allergic or hypersensitive reactions Felbamate or other carbamates or to any of the excipients of formulation which in the opinion of an investigator, would compromise the safety of the subject or the study. 3) History of aplastic anemia or significant hematological disorder (drug induced or idiopathic). 4) History of liver failure or significant liver disease. 5) History of suicidal thinking, imminent risk of suicide, or a danger to self or others as judged by the investigator. 6) History of psychiatric illness or depression. 7) Concurrent use of other drugs known to suppress bone marrow function. 8) Liver enzyme (SGPT and SGOT) levels >2 times the upper limit of normal values at baseline and during the entire study. 9) Clinically significant drop in the red blood cells, white blood cells and platelet counts at baseline and during the entire study. 10) Subjects with any of the following seizure criteria during the study from the date of study onset (baseline): • 2-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. 11) A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Felbamate during the study. 12) Significant history or current evidence of malignancy or chronic infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction, which in the opinion of an investigator, would compromise the safety of the subject or the study; 13) Expected changes in the concomitant medications during the study periods. 14) Expected incompliance with outpatient medications. 15) A history of alcohol or drug dependence by DSM-V-TR criteria during the 6-month period immediately prior to study entry; 16) Positive alcohol breath or urine drug of abuse tests during randomization, or at check-in for housing during each study period. 17) Positive test for Human Immunodeficiency virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibodies. 18) In case of female subjects: Planning to become pregnant Lactating or nursing subjects 19) Participated in any clinical investigation requiring repeated blood sampling, blood donation, or have blood loss of >500 mL in past 8 weeks or participated in any clinical study within the past 3 months prior to first dosing (onset of up-titration) of the study. 20) Any major illness or hospitalization within 90 days prior to first dosing (onset of up-titration) of the study. 21) History of difficulty in accessibility of veins in arms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to assess whether the test product is bioequivalent to reference product based on the evaluation of Cmax,ss and AUC0-Ï?,ssTimepoint: Median Tmax at 2.5 hours with range of 0 hrs to 8 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive statistics for pharmacokinetic (PK) parameters - Cmin,ss, Cavg,ss Degree of Fluctuation, Swing and Tmax,ss; Assessment of safety and tolerability profile of test and reference products. Timepoint: During each study period, pre-dose samples will be collected on days - 8, 9, 10, 18, 19 and 20 for morning dose. Post-dose PK samples will be collected on day-10 and 20 of each study period at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00 and 8.00 hrs post morning dose | — |
Countries
India
Contacts
Public ContactMustafa Pardiwala
Raptim Research Ltd.
Outcome results
None listed