CTRI/2013/05/003665已完成不适用
Multicenter open label randomized crossover bioequivalence trial of BCD-031 (CJSC BIOCAD, Russia) and Xeloda® (Hoffmann-La Roche Ltd, Switzerland) after single oral administration in Colorectal Cancer or Breast Cancer patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Assessment of pharmacokinetic parameters after single administration of the Test drug and the reference drug:
研究概览
简要总结
This is an open label comparative randomized crossover bioequivalence study. The study will include upto 26 patients with colorectal cancer or breast cancer of both sexes aged 18 – 60 years who receive capecitabine monotherapy at a dose of 1250 mg/m2 as a 14-day cycles followed by 7-day intervals. The study will be conducted at 4 sites in India. The primary goal of the study is to study bioequivalence of BCD-031 (capecitabine, CJSC BIOCAD, Russia) and Xeloda® (Hoffmann-La Roche Ltd, Switzerland) after single oral administration in colorectal cancer (CRC) or breast cancer (BC) patients.xml:namespace prefix = "o" ns = "urn:schemas-microsoft-com:office:office" /
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Signing of an informed consent form.
- •Diagnosis colorectal cancer of stage III after surgery or metastatic colorectal cancer or locally advanced or metastatic breast cancer that is resistant to chemotherapy with taxanes or anthracyclines or in patients with contraindications to them.
- •Capecitabine monotherapy as three-week cycles of capecitabine administration for 2 weeks at the dose of 1 250 mg/m², twice a day in the morning and evening (total daily dose of 2500 mg/m²) followed by 7 days break is prescribed to patient.
- •18 – 60 years of age (both inclusive).
- •ECOG score.
- •Anticipated life expectancy ≥ 12 weeks after the study entry.
- •Hemoglobin ≥ 100 g/l, neutrophils ≥ 1,5 x 109/l, platelets ≥ 100 x 109/l, level of liver enzymes (AST, ALT, AP, GGT) does not exceed the upper limit of normal (ULN) more than by 2.5 times, level of total bilirubin and creatinine in plasma is not more ULN.
- •Negative test result for hepatitis B and C, HIV and syphilis not older than 6 weeks before screening.
- •Body mass index (BMI) is in normal range (18.5 – 24.99 kg/m2).
- •Ability of the patient, according to the researcher, to follow the procedures of the Protocol.
- •The study participants of both sexes with reproductive function, as well as their sexual partners, are ready to use reliable birth control methods, ranging from 2 weeks prior to study, and up to 4 weeks after the last dose of study drug. This requirement does not apply to surgically sterilized patients, or who are in menopause (Documentary proved) for the last 2 years. Reliable methods of contraception involve use of barrier method in combination with one of the following: spermicides, intrauterine devices.
- •Patient’s willingness not to drink alcohol for 24 hours prior to the first dose of the test / reference drug and for 48 hours after the last dose.
- •Patient’s willingness not to drink grapefruit juice or products containing grapefruit, for 72 hours prior to the first test / reference drug and within 72 hours after the last dose.
排除标准
- •Confirmed lactose intolerance or other rare genetic diseases, such as intolerance to sucrose, fructose, lactase deficiency and sucrase-isomaltase or glucose-galactose malabsorption.
- •Mental diseases and other conditions that may affect the patients ability to follow the study protocol.
- •Previous surgical procedures on the gastrointestinal tract (except for appendectomy at least 30 days before the screening.) Other surgeries less than 30 days prior to screening.
- •Presence of any set of acute or chronic infections at the time of screening, as well as acute infectious diseases of bacterial, viral or fungal etiology less than 4 weeks before the study began.
- •Inability to insert the venous catheter for blood sampling (e.g., due to diseases of the skin in places of venipuncture).
- •Allergies (e.g., multidrug allergies, anaphylactic shock in history, etc.).
- •Known allergy or intolerance to capecitabine or any other components of the test drug or reference drug and 5-fluorouracil.
- •Documented DPD (dihydropyrimidine dehydrogenase) deficit.
- •Simultaneous therapy with sorivudin or its structural analogs such as brivudin.
- •Disease or other conditions that may affect pharmacokinetics and safety of the drug
- •History of any other neoplasm except for adequately treated basal cell carcinoma or cervical cancer in situ if the period of remission is at least 5 years.
- •Medication, including over-the-counter drugs and dietary supplements, having pronounced effect on hemodynamics, liver function, etc.
- •(barbiturates, omeprazole, cimetidine, etc.), less than 30 days before start of the study, blood transfusion less than 2 weeks prior to screening.
- •Use of oral coumarin anticoagulants.
- •Conditions requiring continuous use of systemic corticosteroids.
- •Pregnancy and breast-feeding.
- •Smoking more than 10 cigarettes a day.
- •Receiving more than 10 alcohol units per week (1 unit.
- •alcohol equivalent to ½ liters of beer, 200 ml of wine or 50 ml of alcohol) or anamnesis data bout alcohol addiction, narcomania or drugs abuse.
- •Donation of 450 ml of blood or plasma within 3 months prior to study enrollment.
- •Participating in any clinical trials of drugs for less than 3 month prior to study enrollment.
- •Simultaneous participation in other clinical trials.
- •Previous participation in this study.
结局指标
主要结局
Assessment of pharmacokinetic parameters after single administration of the Test drug and the reference drug:
时间窗: 0 min, 15 mins, 30 mins, 45 mins, 1hr, 1hr 30 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 10 hrs and 12 hrs after administration of the test or reference drug.
Area under capecitabine «concentration-time» curve at the time of the drug administration up to 12 hours (AUC(0-12))
时间窗: 0 min, 15 mins, 30 mins, 45 mins, 1hr, 1hr 30 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 10 hrs and 12 hrs after administration of the test or reference drug.
次要结局
- 5-FU AUC(0 - 12)(• Area under «concentration-time» curve of capecitabine and 5-FU from the moment of the drug administration to infinity (AUC(0 - ∞)))
研究者
研究点 (4)
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