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A Bioequivalence Study of Capecitabine Tablets 500 mg in Adult Cancer Patients Under Fed Condition

Qilu Pharmaceutical Co., Ltd. · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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breast-cancercolon-cancer
Purpose: To demonstrate the bioequivalence between Capecitabine Tablets 500 mg of Qilu Pharmaceutical Co., Ltd, China in comparison with XELODA® (Capecitabine) Tablets 500 mg, Distributed by Genentech USA, Inc. Design: two treatment, three period, three sequence, reference replicate crossover, single dose. Test Drug: Capecitabine Tablets; Reference drug: XELODA Sample size: Around 45 patients will be enrolled to have at least 39 evaluable patients in the study.
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