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A Study Comparing Capecitabine Capsule 500 mg (Intas Pharmaceuticals Ltd., India) To The Reference Listed Drug Xeloda® (Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of Breast Cancer Or Colorectal Cancer Under Fed Condition

A Multicentre, Randomized, Open Label, Two-Period, Two-Treatment, Two-Way Crossover, Comparative Bioavailability Study At Steady State Comparing Capecitabine Extended Release Capsule 500 mg (Intas Pharmaceuticals Ltd., India) To The Reference Listed Drug Xeloda® (Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of Breast Cancer Or Colorectal Cancer Under Fed Condition - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/03/006741
Enrollment
24
Registered
2016-03-18
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: C189- Malignant neoplasm of colon, unspecified

Interventions

Intervention1: Capecitabine Extended Release Capsule 500 mg (Intas Pharma) : Dose: 1250 mg/m2, Frequency: twice daily, Mode of Administration: orally, Duration of treatment: One week Control Interven

Sponsors

Intas Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or Female >=18 to 2. Patients must have/have had histopathologically /cytologically confirmed breast cancer or colorectal cancer. 3.Patients with a. Metastatic colorectal carcinoma when treatment with fluoro pyrimidine therapy alone is preferred. b. Metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen 4. Eastern Cooperative Oncology Group (ECOG) performance status 5. Patient with adequate bone marrow, renal and hepatic function. 6. Adequate Cardiac function (left ventricular ejection fraction[LVEF] >=50%) 7. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator 8. Able to comply with study requirement in opinion of Principal Investigator. 9. Able to give written informed consent for participation in the trial.

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. Pregnant or breast-feeding female 3. History of drug/alcohol addiction 4. Known brain metastasis 5. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI CTCAE criteria. 6. A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies 7. Known case of HIV infection. 8. Any other condition that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.

Design outcomes

Primary

MeasureTime frame
AUCTimepoint: Day 07 and Day 14—

Secondary

MeasureTime frame
To monitor the safety of the patients who are exposed to the investigational medicinal product.Timepoint: Day 1 to Day 14—

Countries

India

Contacts

Public ContactDr Ankit Ranpura

Lambda Therapeutic Research Ltd

manjunathk@lambda-cro.com07940202290

Outcome results

None listed

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