NCT01846650

A Bioequivalence Study of Capecitabine Tablets

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Metastatic Breast Cancer or Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine tablets	Single oral Capecitabine tablets 2000mg qd
DRUG	XELODA	Single oral XELODA 2000mg qd

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-05-03
• Last updated: 2013-10-01

Locations

1 site across 1 country: China