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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- To characterize the rate and extent of absorption of Melphalan after oral
研究概览
简要总结
This is An open label, multi-centre, randomized, balanced, two treatment, two period, two sequence, single dose, crossover, oral bio-equivalence study in adult patients under fasting conditions. Patients diagnosed with multiple myeloma or ovarian cancer requiring oral melphalan will be included in this study. Study Objective:
To characterize the rate and extent of absorption of Melphalan after oral administration and to assess the bioequivalence of the sponsor’s test product Melphalan Tablets 2 mg relative to that of the reference product ALKERAN® (melphalan) Tablets 2 mg in adult patients of either sex under fasting conditions. and To investigate the safety and tolerability of both the formulations on the basis of clinical and laboratory examination, documentation of the Adverse Events.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with confirmed diagnosis of multiple myeloma or ovarian cancer for whom oral Melphalan is indicated.
- •Patients aged 18 years or above.
- •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.
- •Patients agree to participate in the study and give their written informed consent.
- •Patients who agree to comply with study procedures and the schedule of clinical and follow-up visit.
- •Patients with ECOG (Eastern Cooperative Oncology Group)performance status score of 0-2.
排除标准
- •Patients with known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
- •Patients who received mitomycin C within 8 weeks prior to the first dose of the study.
- •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.
- •Patients having metastatic disease involving the central nervous system.
- •Patients who are scheduled to receive radiotherapy during the study period.
- •Patients with leukocyte count below 3,000 cells/mcL or the platelet count below 100,000 cells/mcL.
- •Previous enrollment in this study or participating in any other study in the past 30 days.
- •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.
- •Patients with history or presence of renal insufficiency and and azotemia.
- •Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis
- •Difficulty in swallowing tablets.
- •Female patients demonstrating a positive pregnancy screen or currently breast-feeding.
结局指标
主要结局
To characterize the rate and extent of absorption of Melphalan after oral
时间窗: The pre-dose (0.00 hour) blood sample (each 4 mL) will be collected within 1 hour prior to dosing. The post-dose blood samples (each 4 mL) will be collected at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 5.00, 6.00 and 8.00 hours after dosing.
administration and to assess the bioequivalence
时间窗: The pre-dose (0.00 hour) blood sample (each 4 mL) will be collected within 1 hour prior to dosing. The post-dose blood samples (each 4 mL) will be collected at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 5.00, 6.00 and 8.00 hours after dosing.
次要结局
- To investigate the safety and tolerability of both the formulations.(basis of clinical and laboratory examination, documentation of the Adverse Events)