CTRI/2011/12/002266Not yet recruitingNot Applicable
A multicentre, randomized, open-label, single dose, two-treatment, three-period, three sequence, partial replicate, crossover, pivotal bioequivalence study of Test capecitabine 500 mg tablets manufactured by Reliance Life Sciences Pvt. Ltd., India with Xeloda® (capecitabine 500 mg) manufactured by Roche Pharma AG, Germany in adult, human, cancer patients under fed condition.
Reliance Life Sciences Pvt Ltd12 sites in 1 country66 target enrollmentStarted: January 2, 2012Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 66
- Locations
- 12
- Primary Endpoint
- •AUC0—t
Study Overview
Brief Summary
This study is a randomized, open-label, single-dose, two-treatment, three-sequence, three-period, partial replicate, crossover, comparative bioequivalence study. Trial comparing bioequivalence of Xeloda 500 mg and Capacitabine 500 mg in 66 patients of locally advanced or metastatic breast cancer or metastatic colorectal cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Males or females 18 to 70 years of age.
- •Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m
- •Patients with histopathologically/ cytologically confirmed breast cancer or colorectal cancer.
- •Cancer patients who are already receiving stable twice daily dosing regimen of capecitabine as prescribed by treating physician.
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Patients with life expectancy of at least 3 months.
- •Patients should be non-smokers.
- •Patients willing to voluntarily provide written informed consent or consent from a Legally Acceptable Representative (LAR), if the patient is not in a condition to give consent.
Exclusion Criteria
- •Patients with inadequate venous access to allow the collection of all samples via venous cannula in the study.
- •Pregnant (female patients with a positive urine pregnancy test at screening and positive serum pregnancy test before period I of hospitalization) or lactating females.
- •Patients with the following abnormal laboratory parameters: a.Serum creatinine more than 2.0 times of upper normal limit b.Aspartate amino transferase (AST) or alanine amino transferase (ALT) more than 2.5 times of upper normal limit c.Alkaline phosphatase ≥ 1.5 times of upper normal limit d.Platelet count les than 100,000/μL.
- •e.Hemoglobin less than 8.0 g/dL.
- •f.Absolute Neutrophil Count (ANC) less than 1.5 x 10 to power 9 /L.
- •Patients with a known hypersensitivity to fluoropyrimidine therapy or known sensitivity to 5- fluorouracil or known Dihydropyrimidine dehydrogenase (DPD) deficiency.
- •Patients with known brain metastasis and/or pre-existing motor or sensory neurotoxicity of severity ≥2 by National; Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) criteria.
- •History or evidence of uncontrolled coagulopathy.
- •History of hereditary galactose/ glucose/ lactase disorders.
- •History or evidence of cardiac disease (Myocardial Infarction in last 6 months, unstable angina, heart failure, uncontrolled ventricular arrhythmia, significant pericardial disease).
- •Patients with a history of alcoholism, found with current alcohol abuse based on Alcohol breath test and/ or drug abuse or who test positive in the urinary screening for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) except as required as medication for the current medical condition.
- •Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
- •Patients having an abnormal serum calcium level at screening visit which as judged by the investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
- •Patients who have participated in any other clinical investigation using experimental drugs or have bled more than 300 mL in the past 3 months.
- •Any other condition which the investigator feels would pose a significant hazard to the patient if IP is administered.
Outcomes
Primary Outcomes
•AUC0—t
Time Frame: •D1, D3, D5 | •D1, D3, D5
Establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters:
Time Frame: •D1, D3, D5 | •D1, D3, D5
•Cmax
Time Frame: •D1, D3, D5 | •D1, D3, D5
Secondary Outcomes
- To monitor adverse events, including laboratory parameters(D1, D3, D5, D6)
- To determine other pharmacokinetic parameters of Test and Reference products.(•Tmax)
Investigators
Study Sites (12)
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