CTRI/2017/04/008429招募中未知
An Open-Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Multi-dose, Steady State, Crossover, Multicenter, Bioequivalence Study of Felbamate Suspension 600 mg/5 mL of Vertice Pharma and Felbatol® (Felbamate) Suspension 600 mg/5 mL of MEDA Pharmaceuticals in Adult Epilepsy Patients under Fasting Conditions
Vertice Pharma0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Males or non pregnant or non lactating females aged between >=18 to <=65 years with epilepsy
- •2. Females of childbearing potential must have a negative pregnancy test performed at screening and at the time of check-in of first period.
- •3. Patients who are receiving Felbamate Suspension daily (Dose: 1800 mg/day in three divided doses [5 mL TDS]) in stable dose as monotherapy or adjunctive therapy since at least 14 days prior to randomization
- •4. Patients with Body Mass Index (BMI) >=18 but <=30 kg/m2. BMI values should be rounded to the nearest integer. (e.g. 30.4 rounds down to 30, while 17.5 rounds up to 18)
- •5. Willing to provide informed consent to participate in this study
- •6. Able to comply with protocol requirements and assessments
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 of 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 â??
- •Absolute Neutrophil Count <= 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 with a history of any blood dyscrasia.
- •12. Patients who are immunodeficient or have a history of immunodeficiency.
- •13. Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days of drug administration.
- •14. Ingestion of any alcoholic, caffeine or xanthine containing food or beverage within 48 hours prior to the initial dose of study medication.
- •15. 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 Investigatorâ??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.
- •16. A positive test result for Hepatitis (includes subtypes B & C), HIV and/or Syphilis (RPR/VDRL).
- •17. Patients with history of alcoholism or drug abuse within last 6 months prior to screening.
- •18. 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.
- •19. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days.
- •20. Participation in any other investigational drug study within 30 days prior to randomization
- •21. 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
研究者
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