To evaluate the bioequivalence of two formulation of capecitabine Tablets 500 mg tablets in patients of Breast Cancer or Colorectal Cancer under fed conditio

Not Applicable

Completed

• Conditions: Health Condition 1: C189- Malignant neoplasm of colon, unspecified

• Registration Number: CTRI/2010/091/000136
• Lead Sponsor: Intas Pharmaceuticals Ltd India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 118

Inclusion Criteria

1.Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2.

2.Patients must have/have had histopathologically /cytologically confirmed breast cancer or colorectal cancer.

3.Patients with BSA between 1.26-1.91 (Both inclusive) should be included.

4.Eastern Cooperative Oncology Group (ECOG) performance status <= 2.

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.Patients with life expectancy of at least 3 months.

9.Able to comply with study requirement in opinion of Principal Investigator.

10.Able to give written informed consent for participation in the trial.

11.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 0 must be negative.

Exclusion Criteria

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. Any of the following cardiac conditions:
a. Unstable angina
b. Myocardial infarction within the past 6 months
c. NYHA (New York State Heart Association) class II-IV heart failure
d. Severe uncontrolled ventricular arrhythmias
e. Clinically significant pericardial disease
f. Electrocardiographic evidence of acute ischemic or active conduction system
abnormalities
g. Any other cardiac illness that could lead to a safety risk to the patient in case of
enrolment in the study
4. History of drug/alcohol addiction
5. Known brain metastasis

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterise the pharmacokinetic profile of the sponsors test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd., India)] relative to that of reference formulation [Xeloda® (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110)] in patients of Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalenceTimepoint: NI

Secondary Outcome Measures

Name	Time	Method
To monitor the safety of the patientsTimepoint: NI