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Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer
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.
Details
| Lead sponsor | The Affiliated Hospital of Qingdao University |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 48 |
| Start date | Mon Dec 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sat Jan 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Patient Participation
Interventions
- 150 mg of Xeloda®
- 150 mg of capecitabine
Countries
China