Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Capecitabine tablets 500 mg: In the current study, patients will be administered 3 tablets of Capecitabine 500 mg (Test Product or Reference Product) as the morning dose on first day of
500 mg tablets: In the current study, patients will be administered 3 tablets of Capecitabine 500 mg (Test Product or Reference Product) as the morning dose on first day of each period. The evening d
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or Female ≥18 years of age and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2 Patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer. Patients must have locally advanced or metastatic breast cancer or metastatic colorectal cancer. Patient will be administered 1500mg of Capecitabine as the morning dose on first day of both periods. Patient only to be included if the second divided dose (evening dose) in both the periods will be safe and effective for the patient as per investigator?s judgement. Daily dose of Capecitabine monotherapy will be based on body surface area (BSA) (2500mg/m2/day in two divided doses), Capecitabine toxicity and underlying disease and general condition of the patient. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Patients with life expectancy of at least 3 monthsPatient with adequate bone marrow, renal and hepatic function. In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 0 (before dosing) 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. Pregnant or breast-feeding female History of drug/alcohol addiction Known brain metastasis Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial. Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI CTCAE criteria. A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study. Known, existing uncontrolled coagulopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterise the pharmacokinetic profile of the sponsor?s test formulation (Capecitabine Tablets 500 mg, Manufactured by Intas Pharmaceutical Ltd., India) relative to that of reference formulation (XELODA® 500 mg tablets, Manufactured by Roche Pharma AG, Germany) in patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patientsTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
NIL
Outcome results
None listed