This randomized, open-label, two-way crossover study will evaluate the relative bioavailabilty and safety of capecitabine rapid disintegrating tablets (RDT) versus commercial Xeloda tablets in patients with colorectal or breast cancer. Patients will be randomized to a sequence of single oral doses of capecitabine RDT or Xeloda on Days 1 and 2 of a 14-day treatment cycle with Xeloda. Follow-up will be 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Unnamed facility
Adelaide, South Australia, Australia
Unnamed facility
Nedlands, Western Australia, Australia
Unnamed facility
Christchurch, New Zealand
Unnamed facility
Grafton, New Zealand
Relative bioavailability: Area under the concentration-time curve (AUC)
Time frame: Multiple sampling pre-dose to 6 hours post-dose
Safety: Incidence of adverse events
Time frame: 30 days
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Unnamed facility
Glasgow, United Kingdom
Unnamed facility
Leeds, United Kingdom
Unnamed facility
London, United Kingdom
Unnamed facility
Newcastle upon Tyne, United Kingdom