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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005185-37 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine RTD | Experimental |
| |
| Xeloda | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine RTD | Drug | single oral dose |
| |
| capecitabine [Xeloda] |
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability: Area under the concentration-time curve (AUC) | Multiple sampling pre-dose to 6 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | South Australia | 5000 | Australia | |||
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| Drug |
single oral dose |
|
| capecitabine [Xeloda] | Drug | standard treatment |
|
| Nedlands |
| Western Australia |
| 6009 |
| Australia |
| Christchurch | 8011 | New Zealand |
| Grafton | 1010 | New Zealand |
| Glasgow | G12 0YN | United Kingdom |
| Leeds | LS9 7TF | United Kingdom |
| London | WC1E 6AU | United Kingdom |
| Newcastle upon Tyne | NE7 7DN | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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