Health Condition 1: null- Patients of locally advanced or metastatic breast cancer or metastatic colorectal cancer or post-surgery stage III (Dukesâ?? stage C) colon cancer
Conditions
Interventions
Intervention1: Capecitabine 500mg (Relicitabine): Patients will be administered drug (Test or the Comparator depending on the Randomization sequence) on Day 1, Day 2, Day 3 of the study (in single tre
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or females 18 to 65 years of age. 2. Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2. 3. Patients in whom capecitabine is indicated as adjuvant treatment following surgery of stage III (Dukesâ?? stage C) colon cancer Or Patients with metastatic colorectal cancer Or Patients with locally-advanced or metastatic breast cancer 4. Cancer patients who are already receiving stable twice-daily dosing regimen of capecitabine as monotherapy as prescribed by treating physician. 5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status 6. Patients with life expectancy of at least 3 months. 7. Patients should be non-smokers. 8. 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: Exclusion Criteria 1. Patients with inadequate venous access to allow the collection of all samples via venous cannula in the study. 2. Pregnant (female patients with a positive serum pregnancy test at screening or positive urine pregnancy test before period I of hospitalization) or lactating females 3. Patients with the following abnormal laboratory parameters: 4. Patients with a known hypersensitivity to fluoropyrimidine therapy or known sensitivity to 5- fluorouracil, receiving concomitant therapy of warfarin,or known Dihydropyrimidine dehydrogenase (DPD) deficiency. 5. Patients with known brain metastasis 6. History or evidence of uncontrolled coagulopathy. 7. History of hereditary galactose/ glucose/ lactase disorders. 8. History or evidence of cardiac disease 9. Patients with a history of alcoholism, or drug abuse 10. Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive. 11. Patients having an abnormal serum calcium level 12. Patients who have participated in any other clinical investigation using experimental drugs 13. Patients with hepatic impairment and severe renal impairment. 14. Any other condition which the investigator feels would pose a significant hazard to the patient if capecitabine is administered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters of Capecitabine during the course of study. PK sampling from Day1 to Day3. 12 PK samples in each period from 0 hours to 8 hours: â?¢ Cmax â?¢ AUC0-t Timepoint: To establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters of Capecitabine during the course of study. PK sampling from Day1 to Day3. 12 PK samples in each period from 0 hours to 8 hours: â?¢ Cmax â?¢ AUC0-t | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To monitor adverse events, including clinically significant laboratory parameters. 2. To determine other pharmacokinetic parameters of Test and Reference products for Capecitabine during the course of study â?¢ Tmax â?¢ AUC0-â?? â?¢ Kel â?¢ t1/2 Timepoint: 1. To monitor adverse events, including clinically significant laboratory parameters. 2. To determine other pharmacokinetic parameters of Test and Reference products for Capecitabine during the course of study â?¢ Tmax â?¢ AUC0-â?? â?¢ Kel â?¢ t1/2 | — |
Countries
India
Contacts
Public ContactDr Sanjeev Hegde
Reliance Life Sciences Pvt.Ltd
Outcome results
None listed