CTRI/2013/12/004205进行中（未招募）未知
An open label, multicentre, randomized, balanced, two-treatment, two-period,two-sequence, single dose, crossover, oral bioequivalence study of Melphalan Tablets 2 mg sponsor company compared with that of ALKERAN® (melphalan) Tablets 2 mg of GlaxoSmithKline, USA in adultpatients under fasting conditions.
Alvogen Pine Brook Inc0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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. Patients with confirmed diagnosis of multiple myeloma or ovarian cancer for whom oral Melphalan is indicated.
- •2. Patients aged 18 years or above.
- •3. Patients who did not receive the last dose of melphalan or nonmelphalan chemotherapy in the last 4 weeks prior to the first dose of the study medication.
- •4. Patients agree to participate in the study and give their written informed consent.
- •5. Patients who agree to comply with study procedures and the schedule of clinical and follow-up visit.
- •6. Patients with ECOG (Eastern Cooperative Oncology Group)performance status score of 0-2.
排除标准
- •1. Patients with known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
- •2. Patients who received mitomycin C within 8 weeks prior to the first dose of the study.
- •3. Patients who had a significant surgery within 2 weeks prior to enrolling in study and as per the investigator, their inclusion may affect the
- •objective of the study.
- •4. Patients having metastatic disease involving the central nervous system.
- •5. Patients who are scheduled to receive radiotherapy during the study period.
- •6. Patients with leukocyte count below 3,000 cells/mcL or the platelet count below 100,000 cells/mcL.
- •7. Previous enrollment in this study or participating in any other study in the past 30 days.
- •8. Any uncontrolled medical problem, e.g. heart, lung disease or clinically significant abnormal laboratory values that in the opinion of the investigator and/or sponsor would preclude safe administration of the study drug.
- •9. Patients with history or presence of renal insufficiency and and azotemia.
- •10. History or presence gastrointestinal ulceration, bleeding and/or perforation.
- •11. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis
- •12. Difficulty in swallowing tablets.
- •13. Positive urine drug screening, alcohol breath analysis, HIV, VDRL/RPR, Hepatitis B & C tests.
- •14. Female patients demonstrating a positive pregnancy screen or currently breast-feeding.
研究者
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