An Open-Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Multi-dose, Steady State, Crossover, Multicentre, Bioequivalence Study of Felbamate Tablet 600 mg of Cadila Healthcare Ltd. and Felbatol® (felbamate) Tablet 600 mg of MEDA Pharmaceuticals in Adult Epilepsy Patients under Fasting Condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Cmaxss, Cminss, AUCtau, Tmaxss, Cav, % Fluctuation, % and Swing will be calculated
研究概览
简要总结
Thesponsor has developed the test formulation. This study is being conducted tocompare the bioavailability and characterize the Pharmacokinetic profile toevaluate the pharmacokinetic bioequivalence of Felbamate Tablet 600 mg ofCadila Healthcare Ltd., India and Felbatol® (felbamate) Tablet 600 mg of MEDAPharmaceuticals and to monitor safety inMale and Non pregnant, non-lactating female epilepsy patients alreadyestablished on felbamate monotherapy or adjunctive therapy to assess thebioequivalence. There are very few felbatol® associated cases of aplastic anemiaand very little information is available regarding its occurrence and relateddeaths. Aplastic anemia can occur within few weeks to months after startingFelbatol® therapy. The patients who are discontinued from felbatol® remain atrisk for developing anemia for a variable and unknown period afterwards. Themost common adverse reactions seen in association with Felbatol® (felbamate) inadults are loss of appetite, vomiting, sleeplessness, nausea, dizziness,sleepiness and headache.
Objective: To evaluate thepharmacokinetic bioequivalence of the test and reference products and tomonitor safety of the patients.
The total number of patients to enroll isaround 30 from India.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males or non pregnant or non lactating females aged between ≥18 to ≤ 65 years with epilepsy 2.Patients who are receiving multiples of 600 mg tablets of felbamate per day (Dose: 1800 or 3600 mg/day in three divided doses) in stable dose as monotherapy or adjunctive therapy since at least 14 days prior to randomization 3.Willing to provide written informed consent to participate in this study 4.Able to comply with protocol requirements and assessments 5.Patients with Body Mass Index (BMI) greater than or equal to 18 but less than or equal to
- •BMI values should be rounded to the nearest integer.
- •(e.g. 30.4 rounds down to 30, while 17.5 rounds up to 18).
排除标准
- •1.History of hypersensitivity to felbamate or any component of the formulation 2.Patients with history of any psychiatric illness, depression, suicidal thoughts or behavior 3.Two-fold increase in the highest, 2-day pre-study seizure frequency during stabilization period 4.Single generalized, tonic-clonic seizure during stabilization period, if none occurred during past 2 months 5.Significant prolongation of generalized, tonic-clonic seizures during stabilization period 6.History of any clinical condition which may affect the absorption and metabolism of the drug e.g. ulcerative colitis or gastrointestinal disease 7.Major surgery to the gastrointestinal tract, the liver or kidney 6 months prior to randomization which may affect the pharmacokinetics of Felbamate 8.Abnormal hematologic function defined as.
- •ï‚§Neutrophils ≤ 1500 cells/mm3 Platelet count ≤100,000/mm3 Hemoglobin ≤ 10 g/dL 9.Impaired hepatic function (serum bilirubin, transaminases or alkaline phosphatase ≥ 2 times the upper limit of normal). 10.Moderate or severe renal disease. 11.Patients who are immunodeficient or have a history of immunodeficiency. 12.Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days of drug administration. 13.Ingestion of any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication. 14.Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication (listed in Appendix-II). They can be allowed depending on Principal Investigator’s discretion in consultation with Medical monitor, if they are kept constant in the last 30 days and are expected to remain constant during the study period. 15.A positive test result for Hepatitis (includes subtypes B & C), HIV and/or Syphilis (RPR/VDRL) 16.Patients with history of alcoholism or drug abuse within last 6 months prior to screening 17.Smokers, who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period. 18.Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days. 19.Participation in any other investigational drug study within 30 days prior to randomization 20.History of any significant cardiovascular, renal, hepatic, neurologic, endocrine dysfunction, inflammatory bowel disease or any other condition which in the opinion of the investigator, may put the patient at risk because of participation in the study.
结局指标
主要结局
Cmaxss, Cminss, AUCtau, Tmaxss, Cav, % Fluctuation, % and Swing will be calculated
时间窗: NIL
次要结局
未报告次要终点