The bioequivalence study of Capecitabine in Patients with Breast or Colorectal Cancer under Fed conditio

Not Applicable

Recruiting

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

Registration Number: CTRI/2013/11/004145

Lead Sponsor: Przedsibiorstwo Farmaceutyczne LEKAM Sp z oo

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 39

Inclusion Criteria

1.Male or Female patients 18-79 years of age (both inclusive) and having a Body Mass Index (BMI) between 18.50 and 30.00 calculated as weight in kg/height in m2.

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

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

4.Patients with life expectancy of at least 3 months.

5.Ability to comply with the study requirement in the opinion of the Principal Investigator.

6.Ability to give a written informed consent for participation in the trial.

7.Adequate cardiac function (left ventricular ejection fraction [LVEF] >=50%)

8.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at the time of check in must be negative

Exclusion Criteria

1.Pregnant or breast-feeding female.

2.Patients with history of arrhythmias, myocardial infarction or any heart failure (NYHA class III-IV) within the last 6 months.

3.Patient with Known brain metastasis.

4.Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by National Cancer Institute (NCI) criteria.

5.Positive results of HBsAg and/or anti-HCV and/or HAV antibodies and/or anti-HIV tests during screening procedures.

6.Participation in another clinical research study within a period of 60 days prior to randomisation.

7.Any other condition that, in the Investigatorâ??s judgment, might increase patientâ??s risk or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.

8.Abnormal baseline findings considered by the Investigator to indicate conditions that might affect study endpoints.

9.Blood loss/blood donation exceeding 1 unit of 350 mL within 30 days prior to randomisation.

10.Heavy smokers, who smoke or use of any tobacco products more than 10 units a day.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters: Cmax and AUC0-t of capecitabine in plasma.Timepoint: 0.250, 0.500, 1.000, 1.500

Secondary Outcome Measures

Name	Time	Method
To assess the safety of the Investigational Medicinal Products (IMPs): physical examination, clinical laboratory tests, vital signs, 12â??lead ECG, ECHO and adverse events <br/ ><br>monitoringTimepoint: On day 3