A comparative study of Capecitabine Capsules 500 mg and Capecitabine tablet 500 mg in patients of breast, colon or rectal cancer
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2018/01/011492
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Male or Female greater than or equal to 18 years and less than or equal to 65 years of age and having a 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. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
4. Patient with adequate bone marrow, renal and hepatic function.
5. Adequate Cardiac function
6. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator
7. Patients with life expectancy of at least 3 months.
8. Able to comply with study requirement in opinion of Principal Investigator.
9. Able to give written informed consent for participation in the trial.
10. In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 1 must be negative.
11. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy
13. In case of Male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug.
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. Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
6. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI CTCAE criteria.
7. A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies
8. Patients with HIV infection.
9. The receipt of an investigational medicinal product or participation in other drug research study within a period of 60 days prior to the first dose of investigational medicinal Product for the current study.
10. 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.
11. Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
12. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
13. Known, existing uncontrolled coagulopathy.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsorâ??s formulation- Capecitabine Extended Release Capsules 500 mg (Test drug, Intas Pharmaceuticals Ltd., India) with Capecitabine) film coated Tablets 500 mg (Reference drug, Intas Pharmaceuticals Ltd., IndiaTimepoint: Pre-dose (Day01, Day 05 to Day 07 and Day 08 Day 12 to Day 14) <br/ ><br> <br/ ><br>Post-dose on Day 07 and Day 14
- Secondary Outcome Measures
Name Time Method To monitor the safety of the patients who are exposed to the investigational medicinal product.Timepoint: From Screening to End of Study