A Randomized, Open Label, Two-Treatment, Multiple Dose, Steady State, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Imatinib Mesylate Tablet 400 mg of Amneal Pharmaceuticals, USA With GLEEVEC® (Imatinib Mesylate) Tablets 400 mg Distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Cmax
研究概览
简要总结
To characterize pharmacokinetic profile of test product compared to that of the corresponding reference product in adult patients, who are diagnosed to have Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor under Fed Conditions.
详细描述
To characterize pharmacokinetic profile of Imatinib Mesylate tablets EQ 400 mg base of Amneal Pharmaceuticals LLC, compared to that of the reference product - GLEEVEC® (imatinib mesylate) tablets 400 mg in adult patients, who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg, and assess their bioequivalence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 55 years (both inclusive) and either sex
- •Diagnosed case of Philadelphia chromosome positive (Ph+) CML patients in chronic phase or GIST and presently being treated with imatinib 400 mg tablets.
- •Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements.
- •Female patients of child bearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing, must be non-lactating at screening and must agree to use effective contraception (barrier or hormonal) for the study period.
排除标准
- •History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator.
- •Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase
- •Abnormal laboratory results as below:
- •History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM).
- •History of therapy with any of the following as per timelines before randomization: inducers of CYP3A4 activity and inhibitors of CYP3A4 activity, within 14 days, investigational product/device within last one month
- •Alcohol or any drug dependence within past one year.
- •Blood donation/loss exceeding 200 ml within last 60 days.
研究组 & 干预措施
Imatinib Mesylate Tablets, 400 mg
Imatinib Mesylate Tablets, 400 mg. Once daily for 14 days.
干预措施: Imatinib Mesylate Tablets, 400 mg (Drug)
Gleevec Tablets, 400 mg
Imatinib Mesylate Tablets, 400 mg. Once daily for 14 days.
干预措施: Imatinib Mesylate Tablets, 400 mg (Drug)
结局指标
主要结局
Cmax
时间窗: Days 5, 6, 7, 12, 13, 14 and 15
Peak maximum concentration over dosing interval in the steady state
AUC0-tau
时间窗: Days 5, 6, 7, 12, 13, 14 and 15
The area under the blood concentration curve versus time, calculated by the trapezoid method, from zero time to the dose interval (tau) in the steady state
次要结局
- Tmax(Days 5, 6, 7, 12, 13, 14 and 15)
- Cmin(Days 5, 6, 7, 12, 13, 14 and 15)
- Cavg(Days 5, 6, 7, 12, 13, 14 and 15)
- Swing(Days 5, 6, 7, 12, 13, 14 and 15)
- Fluctuation Rate(Days 5, 6, 7, 12, 13, 14 and 15)