To monitor the safety of the subjects participating in the study and to assess the bioequivalence of Capecitabine 500 mg Tablets of Sun Pharmaceutical Industries Limited, India and PrXeloda® (Capecitabine) 500 mg Tablets of Hoffmann-La Roche Limited, in cancer patients under fed conditions.

Completed

• Conditions: Dukes’ C colon cancer, metastatic colorectal carcinoma, metastatic breast cancer

• Registration Number: CTRI/2013/08/003922
• Lead Sponsor: Sun Pharmaceutical Industries Ltd

Brief Summary

This study is a randomized, multi center, open label, two treatment, four period, two sequence, single dose, replicated crossover study for monitoring the safety of the subjects participating in the study and to assess the bioequivalence Capecitabine **500 mg** Tablets of Sun Pharmaceutical Industries Limited, India and PrXeloda® (Capecitabine) 500 mg Tablets of Hoffmann-La Roche Limited, in cancer patients under fed conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-09
• Last Update Posted: 2013-10-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects meeting all of the following criteria will be considered for enrollment in the study: i.
• Availability of subject for the entire study period and willingness to adhere to protocol requirements.
• Subjects between 18 to 60 years of age (both inclusive).
• Subjects who have no evidence of underlying disease which in the judgment of the investigator would not make the subject inappropriate for getting enrolled in the study (except Dukes’ C colon cancer/ metastatic colorectal carcinoma/ metastatic breast cancer) during screening, medical history and whose physical examination is performed within 21 days prior to commencement of the study.
• Patients who are taking Capecitabine as a single agent for adjuvant treatment for Dukes’ C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
• Patients who are taking Capecitabine as first-line treatment for metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred.
• Patients who are taking Capecitabine for the treatment of metastatic breast cancer resistant to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, eg, patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents.
• (Only capecitabine as chemotherapeutic agent).
• Patients should not take any adjuvant chemotherapeutic agent except capecitabine throughout the study and 4 weeks before the study.
• Patients whose life expectancy of greater than or equal to 6 months.
• Patients having histologically proven Cancer.
• Patients with Performance ≤ 2 on the ECOG performance scale .
• Subjects whose screening laboratory values are within normal limits or considered by the Investigator/sub-Investigator to be of no clinical significance.
• xii.The subject must sign the written consent form (subject Information and Consent Form) prior to study entry.
• Female Subjects of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
• OR Postmenopausal for at least 1 year.
• OR Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

Exclusion Criteria

• History or presence of significant: i.
• Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Capecitabine and/or any related compounds etc.
• Hepatic impairment, renal (including severe renal impairment), hematological (including leucopenia, thrombocytopenia), endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease which has an impact on subject safety and does not permit dosing of capecitabine.
• Patient having cardiovascular (including coronary artery disease) & pulmonary disorder.
• Cancer patients with a prior history of coronary artery disease, receiving concomitant therapy of warfarin.
• Presence of infections which reduce life expectancy.
• Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
• Patient having clinical evidence of brain metastasis.
• Undergoing concomitant oncologic treatment.
• History of difficulty in swallowing or coming for follow up.
• Clinically significant illness (except Dukes’ C colon cancer/metastatic colorectal carcinoma/metastatic breast cancer) within 4 weeks before the start of the study.
• Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks preceding the study.
• Female subject who is pregnant, lactating or likely to become pregnant or have a positive pregnancy test at screening and prior to check in.
• Positive result to HIV, HCV, RPR and HBsAg. xv.
• Use of enzyme-modifying drugs (like Phenytoin, Fosphenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study.
• Abnormal 12 lead ECG, X-ray 2.
• Donation of blood in the previous 90 days before day 1 of this study 3.
• Participation in another clinical trial within the preceding 90 days of study starts.
• Subjects who have: i.
• Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg ii.
• Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the investigator.
• Pulse rate below 60/min.
• or above 100/min.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
1) To characterize the rate and extent of	Pre Dose samples: 6 ml will be collected within 1.0 hour | Prior to morning dosing. | Post Dose samples: | The post-dose blood samples (1 x 2 mL each) will be collected | at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, | 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of | Morning dose.
bioavailability of the test products in comparison	Pre Dose samples: 6 ml will be collected within 1.0 hour | Prior to morning dosing. | Post Dose samples: | The post-dose blood samples (1 x 2 mL each) will be collected | at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, | 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of | Morning dose.
with the reference product after single dose	Pre Dose samples: 6 ml will be collected within 1.0 hour | Prior to morning dosing. | Post Dose samples: | The post-dose blood samples (1 x 2 mL each) will be collected | at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, | 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of | Morning dose.
Administration under fed conditions.	Pre Dose samples: 6 ml will be collected within 1.0 hour | Prior to morning dosing. | Post Dose samples: | The post-dose blood samples (1 x 2 mL each) will be collected | at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, | 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of | Morning dose.
2) Monitor the safety of the subjects participating	Pre Dose samples: 6 ml will be collected within 1.0 hour | Prior to morning dosing. | Post Dose samples: | The post-dose blood samples (1 x 2 mL each) will be collected | at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, | 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of | Morning dose.
in the study and the tolerability of the test	Pre Dose samples: 6 ml will be collected within 1.0 hour | Prior to morning dosing. | Post Dose samples: | The post-dose blood samples (1 x 2 mL each) will be collected | at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, | 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of | Morning dose.
products in comparison with the reference	Pre Dose samples: 6 ml will be collected within 1.0 hour | Prior to morning dosing. | Post Dose samples: | The post-dose blood samples (1 x 2 mL each) will be collected | at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, | 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of | Morning dose.
Considering adverse events.	Pre Dose samples: 6 ml will be collected within 1.0 hour | Prior to morning dosing. | Post Dose samples: | The post-dose blood samples (1 x 2 mL each) will be collected | at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, | 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of | Morning dose.

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (3)

ASIRVATHAM SPECIALITY HOSPITAL - MADURAI; 🇮🇳 Madurai, TAMIL NADU, India

MEENAKSHI MISSION HOSPITAL - MADURAI; 🇮🇳 Madurai, TAMIL NADU, India

NRR HOSPITAL - BANGALORE; 🇮🇳 Bangalore, KARNATAKA, India

ASIRVATHAM SPECIALITY HOSPITAL - MADURAI

🇮🇳Madurai, TAMIL NADU, India

Dr J Jebasingh

Principal investigator

9442619775

jjebasingh@gmail.com