CTRI/2011/10/002090已完成不适用
A RANDOMIZED, OPEN LABEL, TWO TREATMENT, FOUR PERIOD, TWO SEQUENCE, SINGLE DOSE, REPLICATED CROSSOVER, BIOEQUIVALENCE STUDY OF CAPECITABINE 500MG TABLETS OF SUN PHARMACEUTICAL INDUSTRIES LIMITED, INDIA AND XELODA (CAPECITABINE) 500MG TABLETS OF ROCHE REGISTRATION LTD., IN CANCER PATIENTS UNDER FED CONDITIONS.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 7
- 主要终点
- 1)To characterize the rate and extent of bioavailability of the test products in comparison with the reference product after single dose administration under fed conditions
研究概览
简要总结
This study is a randomized, multicenter, open label, two treatment, four period, two sequence, single dose, replicated crossover study for monitoring the safety of the Patients participating in the study and to assess the bioequivalence of Capecitabine 500mg tablets of Sun Pharmaceutical Industries Limited, India, and Xeloda® (Capecitabine) 500mg of Roche Registration Ltd. in Cancer patients under fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 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 at least 18 years or older.
- •Patients whose body surface area is less than or equal to 1.26 m2, between 1.53 to 1.66 m2, between 1.93 to 2.06 m2 dose is to be given in multiples of 500 mg tablet iii.
- •Patients who have no evidence of underlying disease (except Dukes C colon cancer, metastatic colorectal carcinoma, metastatic breast cancer) during screening medical history and whose physical examination is performed within 21days prior to commencement of the study.
- •Patients who are taking Capecitabine as a single agent for adjuvant treatment for Dukes C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
- •Patients who are taking Capecitabine as first-line treatment for metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred.
- •Patients who are taking Capecitabine for the treatment of metastatic breast cancer resistant to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, eg, patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents.(only capecitabine as chemotherapeutic agent).
- •Patients should not take any adjuvant chemotherapeutic agent except capecitabine throughout the study and 4 weeks before the study.
- •Patients whose life expectancy of greater than or equal to 6 months.
- •Patients having histologically proven Cancer.
- •Patients with Performance less than or equal to 2 on the ECOG performance scale (listed in Appendix III).
- •Patients whose screening laboratory values are within normal limits or considered by the Investigator/sub-Investigator to be of no clinical significance.
- •The subject must sign the written consent form (subject Information and Consent Form) prior to study entry.
- •The subject must have clinically acceptable results from the screening procedure including blood pressure, heart rate, 12 lead ECG, X-Ray, physical exam, medical history, hematology, biochemistry, urinalysis, and infection screen (Hepatitis B Antigen, Hepatitis C Antibody, HIV, VDRL/RPR) xv.
- •Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •Female subjects of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- •OR Postmenopausal for at least 1 year.
- •OR Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the Subject).
排除标准
- •Subjects with a history of clinically significant Cardiovascular, pulmonary, hepatic, renal, hematological (including leucopenia, thrombocytopenia), gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease, in the last 12 months.
- •Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Capecitabine or any related compounds etc.
- •Cancer patients with a prior history of coronary artery disease, receiving concomitant therapy of warfarin.
- •Cancer patients with a prior history of dihydropyrimidine dehydrogenase deficiency.
- •Presence of infections which reduce life expectancy.
- •Undergoing concomitant oncological treatment.
- •History of difficulty in swallowing or coming for follow up.
- •Clinically significant illness (except Dukes C colon cancer, metastatic colorectal carcinoma, metastatic breast cancer) within 4 weeks before the start of the study.
- •Females who are pregnant, breastfeeding, or are likely to become pregnant.
- •Subjects with a history of alcohol, drug or substance abuse in the past 12 months.
- •Subjects who have used enzyme inducing or inhibiting drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) within 30 days of day 1 dosing of the study or any other prescription or over-the-counter medication within 14 days of day 1 dosing of the study.
- •Subjects who have used hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin sub-dermal implants, progesteronereleasing IUDs, post-coital contraception methods) or hormone replacement therapy within 30 days of day 1 dosing of the study.
- •Subjects deemed uncooperative or non compliant.
- •Smoking or consumption of any nicotine products.
- •Subjects who have consumed alcohol within 48 hours prior to day 1 dosing of the study.
- •Subjects who have consumed xanthine-containing products (including caffeine, theobromines, etc.) within 24 hours prior to day 1 dosing of the study.
- •Subjects who have consumed grapefruit, pomelo or grapefruit- or pomelo-containing products within 72 hours prior to day 1 dosing of the study.
- •Subjects who have had an abnormal diet within 30 days prior to day 1 dosing of the study.
- •Subjects who have received an investigational product within the last 2 months prior to day 1 dosing of the study.
- •Abnormal 12 lead ECG xxi.
- •Subjects who have donated a total of 100 mL to 499 mL of whole blood within 30 days prior to day 1 dosing or Subjects who have donated a total of more than 499 mL of whole blood within 56 days prior to day 1 dosing of the study.
- •Subjects who have: Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the Investigator.
- •Pulse rate below 60/min.
- •or above 100/min.
结局指标
主要结局
1)To characterize the rate and extent of bioavailability of the test products in comparison with the reference product after single dose administration under fed conditions
时间窗: Pre-dose blood sample: (1 x 6 mL) will be collected within 1 hour prior to dosing. | Post-dose blood samples (1 x 2 mL each) will be collected at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of morning dose in each period.
2)Monitor the safety of the subjects participating in the study and the tolerability of the test products in comparison with the reference considering adverse events.
时间窗: Pre-dose blood sample: (1 x 6 mL) will be collected within 1 hour prior to dosing. | Post-dose blood samples (1 x 2 mL each) will be collected at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of morning dose in each period.
次要结局
- NA(NA)
研究者
研究点 (7)
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