A Bioequivalence Study of Capecitabine Tablets

CTTQ

Status and phase

Completed

Phase 1

Conditions

Metastatic Breast Cancer or Metastatic Colorectal Cancer

Treatments

Drug: Capecitabine tablets

Drug: XELODA

Study type

Interventional

Funder types

Industry

Identifiers

KPTB-1.1

Details and patient eligibility

About

purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets (Manufactured by Roche Pharma AG)
Experimental Design： Two-period crossover design
Test drug: Capecitabine tablets Reference drug: XELODA
Sample size：24

Enrollment

36 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer，without chemotherapy or only adjuvant chemotherapy, and had previously received one or two standard chemotherapy regimens for patients;
Age: 18-70 years, gender: both，BMI≥17，Eastern Cooperative Oncology Group (ECOG) performance status：0-2，Life expectancy greater than 3 months;
Patients must have normal bone marrow function, liver and kidney function; adequate organ function in the last 1 week, meeting the following: ANC≥1.5×109/L，PLT≥80×109/L, Total bilirubin≤1.5×the upper limit of normal, ALT,AST≤2.5×the upper limit of normal, creatinine≤1.5×the institutional upper limit of normal.
Patients who has retreatment could be enrolled at least 4 weeks after the last chemotherapy and radiotherapy.
Patients must volunteer to participate and sign informed consent form.

Exclusion criteria

Suffering from heart, liver, kidney disease or severe acute and Organ invasion disease;
Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
Pregnant or breast-feeding female
Only bone metastasis lesions, no other measurable lesions
Known brain metastasis or history of organ transplantation
Have long-term systemic steroid therapy
Serious diseases of vital organs; other malignancies which is not cure
Use of chemotherapy in the last 4 weeks
History of drug/alcohol addiction or a positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies
Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI CTCAE criteria or known, existing uncontrolled coagulopathy.
Subjects are thought unsuitable for the study by investigators;
Inability to comply with protocol or study procedures in the opinion of the investigator;