Health Condition 1: null- Locally advanced or metastatic breast cancer or metastatic colorectal cancer
Conditions
Interventions
Intervention1: Capecitabine Tablets
: Dose & Frequency: 500 mg per day
Duration: 3 days (D1, D3, D5)
Mode of Administration: Oral
Control Intervention1: Capecitabine (Xeloda) Tablets: Dose & Frequen
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Males or females 18 to 70 years of age. Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2. Patients with histopathologically/ cytologically confirmed breast cancer or colorectal cancer. Cancer patients who are already receiving stable twice daily dosing regimen of capecitabine as prescribed by treating physician. Patients with Eastern Cooperative Oncology Group (ECOG) performance status Patients with life expectancy of at least 3 months. Patients should be non-smokers. Patients willing to voluntarily provide written informed consent or consent from a Legally Acceptable Representative (LAR), if the patient is not in a condition to give consent.
Exclusion criteria
Exclusion criteria: Patients with inadequate venous access to allow the collection of all samples via venous cannula in the study. Pregnant (female patients with a positive urine pregnancy test at screening and positive serum pregnancy test before period I of hospitalization) or lactating females. Patients with the following abnormal laboratory parameters: a. Serum creatinine more than 2.0 times of upper normal limit b. Aspartate amino transferase (AST) or alanine amino transferase (ALT) more than 2.5 times of upper normal limit c. Alkaline phosphatase >= 1.5 times of upper normal limit d. Platelet count les than 100,000/μL. e. Hemoglobin less than 8.0 g/dL. f. Absolute Neutrophil Count (ANC) less than 1.5 x 10 to power 9 /L. Patients with a known hypersensitivity to fluoropyrimidine therapy or known sensitivity to 5- fluorouracil or known Dihydropyrimidine dehydrogenase (DPD) deficiency. Patients with known brain metastasis and/or pre-existing motor or sensory neurotoxicity of severity >=2 by National; Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) criteria. History or evidence of uncontrolled coagulopathy. History of hereditary galactose/ glucose/ lactase disorders. History or evidence of cardiac disease (Myocardial Infarction in last 6 months, unstable angina, heart failure, uncontrolled ventricular arrhythmia, significant pericardial disease). Patients with a history of alcoholism, found with current alcohol abuse based on Alcohol breath test and/ or drug abuse or who test positive in the urinary screening for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) except as required as medication for the current medical condition. Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive. Patients having an abnormal serum calcium level at screening visit which as judged by the investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial. Patients who have participated in any other clinical investigation using experimental drugs or have bled more than 300 mL in the past 3 months. Any other condition which the investigator feels would pose a significant hazard to the patient if IP is administered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters: â?¢ Cmax â?¢ AUC0â??tTimepoint: â?¢ D1, D3, D5 â?¢ D1, D3, D5 | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine other pharmacokinetic parameters of Test and Reference products. â?¢ Tmax â?¢ AUC0-â?? â?¢ Kel â?¢ t1/2Timepoint: D1, D3, D5 D1, D3, D5 D1, D3, D5 D1, D3, D5;To monitor adverse events, including laboratory parametersTimepoint: D1, D3, D5, D6 | — |
Countries
India
Contacts
Public ContactDr Parvez Kosgi
Reliance Life Sciences P. Ltd.
Outcome results
None listed