A Bioequivalence Study of Capecitabine Tablets

Metastatic Breast Cancer or Metastatic Colorectal Cancer Clinical Trial

Official title: A Bioequivalence Study of Capecitabine Tablets in Patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer

Status Completed

Clinical Trial Summary

1. purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets (Manufactured by Roche Pharma AG)

2. Experimental Design： Two-period crossover design

3. Test drug: Capecitabine tablets Reference drug: XELODA

4. Sample size：24

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Breast Cancer or Metastatic Colorectal Cancer

• NCT number: NCT01846650
• Study type: Interventional
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Status: Completed
• Phase: Phase 1
• Start date: December 2012
• Completion date: June 2013