A Bioequivalence Study of Capecitabine Tablets

Phase 1

Completed

• Conditions: Metastatic Breast Cancer or Metastatic Colorectal Cancer
• Interventions: Drug: Capecitabine tablets; Drug: XELODA

• Registration Number: NCT01846650
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary

1. 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)

2. Experimental Design： Two-period crossover design

3. Test drug: Capecitabine tablets Reference drug: XELODA

4. Sample size：24

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-28
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Capecitabine tablets	Capecitabine tablets	Single oral Capecitabine tablets 2000mg qd
XELODA	XELODA	Single oral XELODA 2000mg qd

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	predose, 0.33,0.67，1,1.5,2，2.5，3,4，5,6，8,hours post-dose

Trial Locations

Locations (1)

First Affiliated Hospital of Fourth Military Medical University; 🇨🇳 Xi an, Shanxi, China