Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer

NCT04420871 ↗

Phase 1 Completed 48 enrolled The Affiliated Hospital of Qingdao University

RandomizedCrossoverOpen-labelTreatment

Summary

A multicenter, randomized, open-label, three-period, and reference-replicated crossover study was conducted in 48 patients with colorectal or breast cancer under fed conditions to assess the bioequivalence between two formulations of capecitabine.

Timeline

Start: 2018-12-10
Primary completion: 2018-12-28
Completion: 2019-01-26

Outcome

Met primary endpoint

paper The 90% confidence intervals for AUC0-t and AUC0-∞ and 95% upper confidence limit for Cmax indicated bioequivalence. PMID 34347254 ↗

Publications

Wang CJ, Li T, Lin PP, Tao Y, Jiang X, Li X, Wen Q, Cao Y. Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients with Colorectal or Breast Cancer Under Fed Conditions: A Multicenter, Randomized, Open-Label, Three-Period, and Reference-Replicated Crossover Study. Adv Ther. 2021 Sep;38(9):4798-4814. doi: 10.1007/s12325-021-01817-4. Epub 2021 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	150 mg	Oral

Indications

No indication recorded.