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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Single oral Capecitabine tablets 2000mg qd
Single oral XELODA 2000mg qd
First Affiliated Hospital of Fourth Military Medical University
Xi’an, Shanxi, China
Area Under Curve (AUC)
Time frame: predose, 0.33,0.67,1,1.5,2,2.5,3,4,5,6,8,hours post-dose
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