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 - NI

Intas Pharmaceuticals Ltd0 个研究点目标入组 66 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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
•ï?§Locally Advanced (non-resectable Stage II or Stage III) or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Gemcitabine as first line treatment)
•ï?§Pancreatic cancer patients previously treated with 5-Fluorouracil
•ï?§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.

•1.Known hypersensitivity reaction to Gemcitabine and any ingredient of the formulation.
•2.Use of any recreational drugs or history of drug addiction.
•3.History of psychiatric disorders.
•4.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
•5.Known case of HIV infection.
•6.Pregnant or breast-feeding women.
•7.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).

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