A multicenter, open-label, randomised, two-treatment, twoÂsequence, cross-over, steady-state clinical bioequivalence study of Felbamate 600mg tablet of Lannett Company Inc., USA with Felbatol® 600mg tablet of Meda Pharmaceutical Inc., USA in adult epileptic (partial seizures with and without generalization) patients already established (run-in) on Felbamate as an adjunctive therapy under fasting state.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- 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 patients
研究概览
简要总结
Background
Felbamate is an anti epileptic drug recommended for use in patientswith refractory partial seizures. Felbamatol 600 mg is a USFDA approved and licensed version of Felbamate manufactured by Meda Pharmaceuticals Inc., U.S.A. Thesaid study will be conducted to provide pharmacokinetic data to establish the bioequivalence ofFelbamate 600mg tablets manufactured by LannettCompany Inc., U.S.A. with Felbatol 600 mg tablet.
Type of study
A multicenter,open-label, randomized, two-treatment, two sequence, cross-over, steady-stateclinical bioequivalence study
Sample size
Thirty eight (38) patientswith refractory partial-onset seizures with and without generalization as perinclusion/exclusion criteria already receiving Felbamate 600mg Q8H and any ofthe following mentioned drugs i.e. valproic acid, levetiracetam, gabapentin, orpregabalin in a stable regimen for at least 7 days prior to randomization willbe enrolled.
Study duration
Except screening,clinical up-titration (3 weeks), clinical stabilization period (1 week) andclinical down-titration period (3weeks), the total study duration (pharmacokineticphase) for patient participation will be 20 days.
Safety monitoring
Throughout the study,subject well being and safety will be monitored. At the end of the study or in caseof a patient withdrawal or termination or dropout, the following procedures will be done: Physicalexamination, vital sign and well being, hematology, biochemistry and urineanalysis, 12-lead ECG, and monitoring for concomitant medication and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •The patients who fulfill all the following inclusion criteria will be included: i.Patients should be in the range of
- •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 volunteer’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. ‘Moderate smokers’ are defined as those who smoke 10 cigarettes or less per day, ‘Ex-smokers’ 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.
排除标准
- •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): 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 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.
- •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.
结局指标
主要结局
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 patients
时间窗: 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.
次要结局
- To evaluate safety of administration of Felbamate Tablets 600 mg in refractory partial epilepsy patients stabilised on Felbamate.(Safety monitoring will be conducted throughout the study.)