Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Capecitabine Tablets USP 500 mg,Each film -coated tablet contains: Capecitabine USP 500 mg,Manufactured by: Intas Pharmaceuticals Limited, India.: The recommended dose of XELODA® is 12
equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest
period given as 3 week cycles
Control Intervention1: Xeloda®
(capecitabine) Tablets 500 mg,Each tablet contains: Capecitabine 500 mg,Distributed by: Roche Laboratories Inc., New Jersey 07110: The recommended dose of XELODA®
is 1250 mg/m2 administered orally twice daily (morning
and evening
equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest
period given as 3 week cycles
Sponsors
Intas Pharmaceuticals Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2. 2.Patients must have/have had histopathologically /cytologically confirmed breast cancer or colorectal cancer. 3.Patients with BSA between 1.26-1.91 (Both inclusive) should be included. 4.Eastern Cooperative Oncology Group (ECOG) performance status 5.Patient with adequate bone marrow, renal and hepatic function. 6.Adequate Cardiac function (left ventricular ejection fraction [LVEF] >=50%). 7.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator 8.Patients with life expectancy of at least 3 months. 9.Able to comply with study requirement in opinion of Principal Investigator. 10.Able to give written informed consent for participation in the trial. 11.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 0 must be negative.
Exclusion criteria
Exclusion criteria: Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency. 2. Pregnant or breast-feeding female 3. Any of the following cardiac conditions: a. Unstable angina b. Myocardial infarction within the past 6 months c. NYHA (New York State Heart Association) class II-IV heart failure d. Severe uncontrolled ventricular arrhythmias e. Clinically significant pericardial disease f. Electrocardiographic evidence of acute ischemic or active conduction system abnormalities g. Any other cardiac illness that could lead to a safety risk to the patient in case of enrolment in the study 4. History of drug/alcohol addiction 5. Known brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterise the pharmacokinetic profile of the sponsors test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd., India)] relative to that of reference formulation [Xeloda® (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110)] in patients of Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalenceTimepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patientsTimepoint: NIL | — |
Countries
India
Contacts
Public ContactMr Priyajeet Parekh
NIL
Outcome results
None listed