CTRI/2009/091/000708已完成1 期
A randomized, open label, multi-dose, two treatment, two-way crossover, steady state, bioequivalence study comparing Amneal Pharmaceuticals Felbamate 600 mg/5 ml oral suspension to the Reference Listed Drug (RLD), Felbatol® (felbamate) 600 mg/5 ml oral suspension Manufactured by MEDA Pharmaceuticals (formerly Medpointe) in adult male and non-pregnant female epilepsy patients under fasting condition
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
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.Male and female patients, 18 years of age or older, diagnosed with refractory epilepsy, who do not respond adequately to alternative treatment.
- •2.Patients should be on a stable dose of Felbamate (1800 to 4800 mg/day given in divided doses three or four times per day) for at least two weeks prior to randomization
排除标准
- •Patients with concurrent psychiatric diagnosis, hematology counts below LLN, history of aplastic anemia or bone marrow suppression, serum transaminases 2x ULN or history or evidence of hepatic dysfunction.
研究者
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