Bioequivalence study ofCapecitabine tablets 500 mg

Not Applicable

• Conditions: Health Condition 1: null- Metastatic cancer patients

• Registration Number: CTRI/2018/05/014342
• Lead Sponsor: Mega Pharma SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients of 18 to 60 years of age (both years inclusive) with established cases of cancer, who are already receiving a stable twice-daily dosing regimen in multiples of 500 mg tablet (i.e., twice daily, equivalent to 2500 mg/m2 total daily dose, for 2 weeks followed by a 1 week rest period given as 3 week cycles) as prescribed by the reference product label.

Patients whose body surface area is <= 1.25 m2, between 1.52 â?? 1.65 m2, between 1.92 â?? 2.05 m2 & dose is to be given in multiples of 500 mg tablet

Subjects who have no evidence of underlying disease (except Dukesâ?? 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 Dukesâ?? C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferre

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 having no brain metastasis.

ï?? 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. Specifically, System Lab value ANC >= 1.5 � 103 /μl, Hb >= 10.0 g/dL, Platelets >= 1 lac/μl, Bilirubin <= 1.5 mg/dL, AST & ALT <= 2

x Upper Normal Limit or <= 5 Ã? Upper Normal Limit (for liver mets)

Male Subjects must agree to comply with two highly effective contraceptive methods comprisinga barrier method (condom or occlusive cap plus spermicidal) for up to the last drug administration,and refrain from fathering a child for at least two (2) weeks following the last study drug administration. Periodic abstinence and withdrawal are not acceptable methods of contraception.

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

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.

Cancer patients with a prior history of coronary artery disease, receiving concomitant therapy of

warfarin.

Cancer patients with a history of dihydropyrimidine dehydrogenase deficiency.

Presence of infections which reduce life expectancy.

Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within

past one year.

Undergoing concomitant oncologic treatment.

Smoking (>= 10 cigarettes/day) or consumption of tobacco products (>= 4 chews/day).

History of difficulty in swallowing or coming for follow up.

Clinically significant illness (except Dukesâ?? 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.

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.ï?? 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