A Randomized, Open-label, Single Dose, Two-way Cross-Over Study to Investigate the Relative Bioavailability of Capecitabine in Rapid Disintegrating Tablets (RDT) Versus the Commercial Xeloda® Tablets Following Oral Administrations in Adult Patients With Solid Tumours
Inclusion Criteria:
- Adult patients,>/= 18 years of age
- Histological/cytological confirmation of colorectal or breast cancer
- Patient is ambulatory and has a Karnofsky performance status of > 70%
- Body surface area between 1.5 and 2.0 m2
- Either:
- Due to receive Xeloda as monotherapy or as combination therapy as per their treating
physician's treatment plan, or
- Currently receiving Xeloda monotherapy and in the investigator's opinion able to
tolerate study drug dose on Day 1 and Day 2
Exclusion Criteria:
- Any contraindication to Xeloda
- Received Xeloda in the 6 days prior to Day 1
- Subjects with organ allografts (other than autologous bone marrow transplant after
high dose chemotherapy)
- Renal impairment
- Pregnant or lactating females
- Participation in an investigational drug study within 28 days prior to screening
- Lack of physical integrity of the upper gastrointestinal tract, or clinically
significant malabsorption syndrome
- Serious uncontrolled intercurrent infections
- History of clinically significant coronary artery disease
- Concomitant treatment with warfarin
- Known dihydropyrimidine dehydrogenase deficiency