To assess the safety and tolerability of a single oral dose of the Capecitabine test and reference formulations.

Completed

• Conditions: advanced or Metastatic Breast Cancer or colorectal Cancer or advanced gastric cancer

• Registration Number: CTRI/2012/07/002778
• Lead Sponsor: Hetero Labs Ltd

Brief Summary

This is an open-label, randomized, single dose, and two treatment periods, two sequence cross-over study in locally advanced breast cancer or metastatic breast cancer or colo rectal cancer or advanced gastric cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-20
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 1.Established cases of advanced breast cancer or metastatic breast cancer or colo-rectal cancer or advanced gastric cancer (in combination with a platinum based regimen), who are already receiving a stable twice-daily dosing regimen in multiples of 500 mg tablet.
• 2.Life expectancy of at least 3 months 3.Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria

• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the subject in case of participation in the study.
• Positive alcohol or drug abuse test at baseline.
• Diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively.
• Have received any live or live attenuated vaccines within 2 months prior to randomization.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishing the bioequivalence between test and reference	Day 1 and Day 2

Secondary Outcome Measures

Name	Time	Method
AUClast AUCinf Cmax λz Tmax and T1/2 and other parameters as appropriate from plasma concentration time	Day 1 and Day 2

Trial Locations

Locations (6)

BIBI general hospital and cancer centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

ClinSync Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Curie Manavata cancer centre; 🇮🇳 Nashik, MAHARASHTRA, India

Dr .C. T. Satheesh; 🇮🇳 Bangalore, KARNATAKA, India

Life Research Centre; 🇮🇳 Surat, GUJARAT, India

Vikram Hospitals Bengaluru Pvt. Ltd.; 🇮🇳 Bangalore, KARNATAKA, India

BIBI general hospital and cancer centre

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr S Mallik

Principal investigator

040-24528422

drmallik.onco@gmail.com