The study will be conducted to monitor safety and compare the bioavailability of Capecitabine 500 mg tablets of Sun Pharmaceutical Industries Ltd., India, and Xeloda (Capecitabine) 500 mg of Roche Registration Ltd., after administration of single dose, in Cancer patients under fed conditions.
Completed
- Conditions
- Cancer
- Registration Number
- CTRI/2011/12/002288
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd
- Brief Summary
Thisstudy is a randomized, multi center,open label, two treatment, three period, three sequence, single dose,reference-replicated crossover study, for monitoring the safety of the Patients participating inthe study and to assess the bioequivalence of Capecitabine 500mg tablets of SunPharmaceutical Industries Limited, India, and Xeloda (Capecitabine) 500mg ofRoche Registration Ltd. in Cancer patients under fed conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Availability of patients for the entire study period and willingness to adhere to protocol requirements.
- Subjects between 18 to 60 years of age.
- Patients whose body surface area is equal to or less than 1.25 m2 , between 1.52 to 1.65 m2 , between 1.92 to 2.05 m2 and dose is to be given in multiples of 500 mg tablet.
- Subjects who have no evidence of underlying disease (except Dukes’ C colon cancer/ metastatic colorectal carcinoma/ metastatic breast cancer) during screening medical history and whose physical examination is performed within 21days 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).
- viii.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 having no brain metastasis.
- xii.Patients with Performance less than or equal to 2 on the ECOG performance scale.
- xiii.Subjects whose screening laboratory values are within normal limits or considered by the Investigator/sub-Investigator to be of no clinical significance.
- xiv.Informed consent form given in written form according to section 9.3 of the protocol.
- xv.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.
- Cardiovascular (including coronary artery disease), pulmonary, hepatic impairment, renal (including severe renal impairment), hematological (including leucopenia, thrombocytopenia), gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease.
- iii.Cancer patients with a prior history of coronary artery disease, receiving concomitant therapy of warfarin.
- iv.Cancer patients with a history of dihydropyrimidine dehydrogenase deficiency.
- v.Presence of infections which reduce life expectancy.
- Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
- vii.Undergoing concomitant oncologic treatment.
- viii.Smoking (more than or equal to 10 cigarettes/day) or consumption of tobacco products ( more than or equal to 4 chews/day).
- 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.
- 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. xiv.
- Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine) in the previous 30 days before day 1 of this study.
- Abnormal 12 lead ECG, X-ray.
- Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study.
- Participation in another clinical trial within the preceding 90 days of study starts.
- subjects who have: •Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg •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 bioavailability of the test products in comparison with the reference product after single dose administration under fed conditions. The pre-dose blood sample (1 x 6 ml) will be collected within 1 hour prior to dosing. The post-dose blood samples (1 x 2ml 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 in the study and the tolerability of the test products in comparison with the reference considering adverse events. The pre-dose blood sample (1 x 6 ml) will be collected within 1 hour prior to dosing. The post-dose blood samples (1 x 2ml 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 (7)
Asirvatham Speciality hospital
🇮🇳Madurai, TAMIL NADU, India
BIBI GENERAL HOSPITAL & CANCER CENTER
🇮🇳Hyderabad, ANDHRA PRADESH, India
Erode Cancer Center
🇮🇳Erode, TAMIL NADU, India
KOVAI MEDICAL CENTER & HOSPITAL LTD
🇮🇳Coimbatore, TAMIL NADU, India
Manu Hospital & Research Center
🇮🇳Jaipur, RAJASTHAN, India
NRR Hospital
🇮🇳Bangalore, KARNATAKA, India
Seeta devi Hospital
🇮🇳Jaipur, RAJASTHAN, India
Asirvatham Speciality hospital🇮🇳Madurai, TAMIL NADU, IndiaDr JJebasinghPrincipal investigator919442619775jjebasingh@gmal.com