An Open-Label, Randomised, Four-Period, Two-Treatment, Two-Sequence, Full Replicate, Crossover, Multicentre, Single-Dose Bioequivalence Study of Capecitabine Tablets 500 mg of Hetero Labs Limited and XELODAÂ® (Capecitabine) Tablets 500 mg of Roche Registration Limited in Metastatic Breast Cancer, Dukeâ??s C Colon Cancer or Metastatic Colorectal Cancer subjects Under Fed Conditions.

Hetero Labs Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 已完成
发起方: Hetero Labs Limited

研究概览入排标准研究者记录与标识符相似试验

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) Subject must be receiving stable doses of Capecitabine (e.g.: 2500 mg/m2/day in two divided doses, for 2 weeks followed by a 1 week rest (treatment free) period given as total 3 weeks cycle) as monotherapy for the treatment of metastatic breast cancer, Dukeâ??s stage C Colon cancer following complete resection, and metastatic colorectal carcinoma. Subjects must have received at least one cycle previously.
•2) Males or non-pregnant or non-lactating females of age >= 18 years and <= 65 years.
•3) Subject having body surface area between 1.27- 2.0 m2 (both inclusive) measured as per the Du Bois formula.
•4) Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (Î²-HCG) pregnancy test at the time of screening & negative urine pregnancy test at the time of stabilization period (if applicable) and check-in of each period.
•5) Female of childbearing potential willing to use acceptable forms of contraception during study period till 6 months after last dose. Acceptable form of contraception is listed below: i. Non Hormonal Intrauterine device in place for at least 3 months prior to the start of the study, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilisation, or iv. Practicing sexual abstinence throughout the course of the study
•Females will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
•i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Subject with 6-12 months of spontaneous amenorrhea with serum FSH levels > 30 mIU/m, or. iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv. Total hysterectomy and an absence of bleeding for at least 3 months.
•6) Male subject must agree to use a barrier method of contraception from ICF signing till 3 months after last dose of IP, if sexually active with a female of childbearing potential.
•7) Life expectancy of at least 3 months.
•8) Hb > 9 gm/dL, ANC > 1500/mm3 and Platelets > 100000/microliter.
•9) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
•10) Subject willing to not change their concurrent medications during the study.
•11) All subjects should have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 18.
•12) Able to comply with protocol requirements and assessments.
•13) Able to give written informed consent to participate in the study
•14) All subjects should be judged eligible by the principal investigator or co-investigator or physician before randomization.

排除标准

•1) History of allergic responses to Capecitabine, 5-fluorouracil or other related drugs and any of its formulation ingredients/excipients.
•2) Subject having signs and symptoms suggestive of COVID-19 (such as fever, cough, and difficulty in breathing).
•3) Subject with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
•4) Subject receiving concomitant therapy of warfarin (coumarin anticoagulants) or history of usage of coumarin anticoagulants in the previous three months prior to enrolment
•5) Known history of (Dihydropyrimidine Dehydrogenase) DPD deficiency.
•6) Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days of drug administration of stabilization (if applicable) or period I to throughout the study duration.
•7) Ingestion of any alcoholic, caffeine or xanthine containing food or beverage for at least 48 hours prior to the initial dose of study medication to throughout the study duration.
•8) Use of enzyme-modifying drugs (CYP2C9) within 30 days prior to receiving the first dose of study medication. (Refer section 7.5) They can be allowed depending on Principal Investigatorâ??s discretion in consultation with medical monitor, if they are kept constant in the last 30 days and are expected to remain constant during the study period.
•9) History of moderate to severe renal disease (creatinine clearance < 50 mL/min).
•10) Impaired hepatic function (bilirubin >= 1.5 times the upper limit of normal and/or transaminases or alkaline phosphatase >= 2.5 times the upper limit of normal) [Transaminases or alkaline phosphatase are allowed up to 5 times ULN in case of liver metastasis].
•11) Major surgery to the gastrointestinal tract, liver or kidney within 4 weeks of study entry which may impact on the pharmacokinetics of Capecitabine.
•12) Participation in any investigational drug study within 30 days prior to screening.
•13) History of difficulty in swallowing of study medication, or any other gastrointestinal disease which could affect drug absorption.
•14) Subject with active GI disease including any GI surgery that in the opinion of the investigator would interfere with the absorption of study medication.
•15) Subject with History of coronary artery disease.
•16) Subject with prolonged QT interval (as per Bazetteâ??s formula, refer Appendix I) or clinically significant ECG changes, a) For male- > 450 ms b) For female- > 470 ms.
•17) Known, existing uncontrolled coagulopathy.
•18) Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days prior to screening.
•19) History of drug dependence, history of alcoholism in the past 2 years prior to screening.
•20) Smokers, who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period.
•21) History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
•22) A positive screen for hepatitis (includes subtypes B & C) or HIV antibody or syphilis (RPR/VDRL).
•23) Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub Investigator, could contraindicate the subjectâ??s participation in this study.

研究者

发起方

Hetero Labs Limited

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