A clinical study to demonstrate bioequivalence between two drugs Xeloda (Reference) and Capecitabine 500 mg Tablets (Test) in cancer patients
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https://www.omicsdi.org/dataset/ecrin-mdr-crc/2573355
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资源简介:
Intervention1: Capecitabine Tablets
: Dose & Frequency: 500 mg per day
Duration: 3 days (D1, D3, D5)
Mode of Administration: Oral
Control Intervention1: Capecitabine (Xeloda) Tablets: Dose & Frequency: 500 mg per day
Duration: 3 days (D1, D3, D5)
Mode of Administration: Oral
Primary outcome(s): Establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters:
â?¢Cmax
â?¢AUC0tTimepoint:
â?¢D1, D3, D5
â?¢D1, D3, D5
Study Design: Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
创建时间:
2012-02-15



