Bioequivalence study of Capecitabine 500 mg with XelodaÂ®(capecitabine) tablets 500 mg in Locally Advanced Breast Cancer or Metastatic Breast Cancer or Colorectal Cancer patients under fed conditio

Phase 1

Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Registration Number: CTRI/2012/08/002903

Lead Sponsor: Evenus Pharmaceutical Laboratories Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 110

Inclusion Criteria

1.Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2. 2.Patient with adequate bone marrow, renal and hepatic function. 3.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator 4.Patients with life expectancy of at least 3 months (as per the

Investigatorâ??s discretion) 5.Able to comply with study requirement in opinion of Principal

Investigator 6.Able to give written informed consent for participation in the trial 7.Patients should have their BSA (as per the DuBois formula) between

1.26-1.91 m2 (Both inclusive)

Exclusion Criteria

1.Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine

Dehydrogenase) deficiency. 2.History of drug/alcohol addiction. 3.Known brain metastasis 4.A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies 5.Known HIV infection.6.History of drug/alcohol addiction. 7.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.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterise the pharmacokinetic profile of the sponsorâ??s test formulation <br/ ><br>[Capecitabine Tablets 500 mg] relative to that of reference formulation [XelodaÂ® Tablets 500 mg] in patients with <br/ ><br>Metastatic Breast Cancer or Colorectal Cancer under fed condition and to <br/ ><br>assess the bioequivalence.Timepoint: The venous blood samples will be withdrawn Pre-dose and 0.25(15 min), 0.5(30 min), 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.5, 4, 5, <br/ ><br>6, 8, 10 hr post-dose in each period administration

Secondary Outcome Measures