Bioequivalence study of Capecitabine 500 mg with XelodaÂ®(capecitabine) tablets 500 mg in Locally Advanced Breast Cancer or Metastatic Breast Cancer or Colorectal Cancer patients under fed condition

A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine tablets 500 mg with XelodaÂ® (capecitabine) tablets 500 mg in Locally Advanced Breast Cancer or Metastatic Breast Cancer or Colorectal Cancer patients under fed condition. Capecitabine is the test drug (Manufactured by: Jiangsu Hengrui Medicine Co.,China). Xeloda is the reference drug (Distributed by:Roche Registration Limited,UK)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/08/002903

Enrollment

110

Registered

2012-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Capecitabine Tablets 500mg: Capecitabine Tablets 500 mg will be administered as a single oral dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. C

Eligibility

Inclusion criteria

Inclusion criteria: 1.Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2. 2.Patient with adequate bone marrow, renal and hepatic function. 3.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator 4.Patients with life expectancy of at least 3 months (as per the Investigatorâ??s discretion) 5.Able to comply with study requirement in opinion of Principal Investigator 6.Able to give written informed consent for participation in the trial 7.Patients should have their BSA (as per the DuBois formula) between 1.26-1.91 m2 (Both inclusive)

Exclusion criteria

Exclusion criteria: 1.Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency. 2.History of drug/alcohol addiction. 3.Known brain metastasis 4.A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies 5.Known HIV infection.6.History of drug/alcohol addiction. 7.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.

Design outcomes

Primary

Measure	Time frame
To characterise the pharmacokinetic profile of the sponsorâ??s test formulation [Capecitabine Tablets 500 mg] relative to that of reference formulation [XelodaÂ® Tablets 500 mg] in patients with Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: The venous blood samples will be withdrawn Pre-dose and 0.25(15 min), 0.5(30 min), 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.5, 4, 5, 6, 8, 10 hr post-dose in each period administration	—

Measure

Time frame

To characterise the pharmacokinetic profile of the sponsorâ??s test formulation [Capecitabine Tablets 500 mg] relative to that of reference formulation [XelodaÂ® Tablets 500 mg] in patients with Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: The venous blood samples will be withdrawn Pre-dose and 0.25(15 min), 0.5(30 min), 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.5, 4, 5, 6, 8, 10 hr post-dose in each period administration

—

Secondary

Measure	Time frame
To monitor safety of the patients, who are exposed to the Investigational Medicinal ProductTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Ankit Ranpura

Lambda Therapeutic Research Ltd

praveenshetty@lambda-cro.com079-40202020

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026