Clinical trial · Interventional
Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer
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
NCT04420871CI-TRIAL-00045457completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patient Participation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 150 mg of capecitabine | Drug | — | UNRESOLVED |
| 150 mg of Xeloda® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- capecitabine reference formulation at a single dose of 150 mg
- description
- 150 mg of Xeloda® produced by Genentech USA, Inc., a subsidiary of the company, was used as the reference intervention in this study.
- interventionNames
- Drug: 150 mg of Xeloda®
- type
- EXPERIMENTAL
- label
- capecitabine test formulation at a single dose of 150 mg
- description
- The tablet of 150 mg of capecitabine from Qilu Pharmaceutical Co., Ltd. (17H0053DE4, Jinan, Shandong Province, China) was used as the test formulation.
- interventionNames
- Drug: 150 mg of capecitabine
Primary outcomes (3)
- measure
- Peak Plasma Concentration (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 28 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically or cytologically confirmed colorectal or breast cancer receiving capecitabine monotherapy or combination chemotherapy. * Eligible patients were within 18-70 years of age. * ECOG score was 0-2. * Left ventricular ejection fraction (LVEF) \> 50%. * There was no serious persistent toxicity to capecitabine treatment before screening (laboratory tests ≤ grade 1 (NCI CTCAE 5.0 standard) * Hand-foot syndrome ≤ grade 2 after recovery from the previous treatment period). Exclusion Criteria: * Patients were known allergy to fluorouracil or 5-fluorouracil. * Patients with complete lack of known dihydropyrimidine dehydrogenase (DPD) activity. * Patients with abnormal hepatic and renal function (serum creatinine≤ 1.5 ×ULN; CLcr ≥ 51 mL/min; bilirubin≤ 1.5 ×ULN; AST, ALT≤2.5×ULN) * Needed to accept phenytoin, warfarin, other coumarin derivatives anticoagulants, folic acid, and CYP2C9 substrates during the research. * Patients with brain metastases or other metastases of the central nervous system (except those who were treated at least 6 months prior to the start of the study and were stable and asymptomatic).
References
Publications (1)
- DERIVEDWang 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. PMID 34347254