A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, single dose bioequivalence study comparing Gemcitabine injection (Manufactured by: Intas Pharmaceuticals Ltd.) to the reference listed drug Gemzar injection (Eli Lilly and Company, Indianapolis, IN 46285, USA) in patients with Pancreatic or Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 7
- 主要终点
- To characterize the pharmacokinetic profile of the sponsor’s test formulation relative to that of reference formulation in patients and to assess the bioequivalence
研究概览
简要总结
Gemcitabine injection is a cytotoxic drug. It wouldnot be appropriate to conduct this study on healthy volunteers. Therefore thebioequivalence study is proposed to be carried out on patients of Pancreatic orOvarian cancer, who in the opinion of their treating physicians are candidatesfor Gemcitabine injection therapy. A sample size of 44 patients wouldbe sufficient to establish bioequivalence between formulations with adequatepower.
Primary Objective:
To characterize the pharmacokinetic profile of thesponsor’s test formulation relative to that of reference formulation inpatients and to assess the bioequivalence
Secondary Objective:
To monitor the safety of the patients,who are exposed to the Investigational Medicinal Product
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Able to give written informed consent for participation in the trial.
- •2.Male and female patients between the ages of 18 and 65 years.
- •3.Patients with Histo-pathologically or through Fine Needle Aspiration Cytology (FNAC) confirmed Locally Advanced (non-resectable Stage II or Stage III) or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Gemcitabine as first line treatment) ‘OR’ Pancreatic cancer patients previously treated with 5-FU ‘OR’ Advanced Ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy (Gemcitabine in combination with Carboplatin) 4.Recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
- •5.Patients if already on Radiotherapy, a gap of at least one week shall be maintained between the last day of radiotherapy and the day of screening 6.Patients with life expectancy of at least 2 months 7.Able to comply with study requirement in opinion of Principal Investigator.
- •8.Adequate hepatic, renal and hematopoietic function.
- •9.ECOG Performance Status- 0, 1 or 2 10.In case of female patient the serum pregnancy test at screening visit must be negative.
排除标准
- •Known hypersensitivity reaction to Gemcitabine and any ingredient of the formulation.
- •Use of any recreational drugs or history of drug addiction.
- •History of psychiatric disorders.
- •A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- •Known case of HIV infection.
- •Pregnant or breast-feeding women.
- •The receipt of an investigational drug or product, or participation in a drug research study within a period of 60 days prior to the first dose of investigational Product (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study).
- •Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
结局指标
主要结局
To characterize the pharmacokinetic profile of the sponsor’s test formulation relative to that of reference formulation in patients and to assess the bioequivalence
时间窗: Blood samples will be collected at following time points: | Pre-infusion (within 60 minutes prior to infusion), 5, 15 and 30 min during the infusion and 5 min, 10 min, 20 min, 0.5 hrs, 0.75 hrs, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 6 hrs, 8 hrs and 10 hrs post-infusion (total 16 samples)
次要结局
- To monitor the safety of the patients, who are exposed to the Investigational Medicinal Product(Screening, Day 0 (check in for period I), Day 07 (check in for period II), End of study.)