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To assess the safety and tolerability of a single oral dose of the Capecitabine test and reference formulations

A multicentre, randomized, open label, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg (Manufactured by: Hetero Labs Ltd, India) and the reference listed drug Xeloda® (Capecitabine) Tablets 500 mg (Distributed by Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA 94080) in locally advanced or Metastatic Breast Cancer or Colorectal Cancer adult subjects already receiving a stable twice-daily dosing regimen as prescribed by the reference product label under fed condition.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/08/002940
Enrollment
64
Registered
2012-08-31
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: null- locally advanced or Metastatic Breast Cancer or Colorectal Cancer adult subjects.

Interventions

Intervention1: Capecitabine Tablets 500 mg, manufactured by Hetero labs ltd.: The recommended dose of capacitabine is 1250 mg/m2 administered orally twice daily (morning and evening
equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles Intervention2: Capecitabine Tablets 500 mg,manufactured by Hetero labs ltd.: The recommen
equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles Control Intervention1: Xeloda® (Capecitabine) Tablets 500 mg (Distributed by Genentech
equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles

Sponsors

Hetero Labs Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Established cases of advanced breast cancer or metastatic breast cancer or colo-rectal cancer who are already receiving a stable twice-daily dosing regimen in multiples of 500 mg tablet. 2.Life expectancy of at least 3 months 3.Eastern Cooperative Oncology Group (ECOG) performance status

Exclusion criteria

Exclusion criteria: 1. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the subject in case of participation in the study. 2. Positive alcohol or drug abuse test at baseline. 3. Diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively. 4. Have received any live or live attenuated vaccines within 2 months prior to randomization.

Design outcomes

Primary

MeasureTime frame
Establishing the bioequivalence between test and referenceTimepoint: Day 1 and Day 2—

Secondary

MeasureTime frame
AUClast AUCinf Cmax λz Tmax and T1/2 and other parameters as appropriate from plasma concentration timeTimepoint: Day 1 and Day 2—

Countries

India

Contacts

Public ContactDrChinna Babu

ClinSync Clinical Research Pvt. Ltd

suresh@clinsynccro.com040-24203000

Outcome results

None listed

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