A bioequivalence study of Capecitabine tablets in adult human cancer patients.
- Conditions
- Health Condition 1: null- Adult human cancer patients
- Registration Number
- CTRI/2017/01/007627
- Lead Sponsor
- Shilpa Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 78
The patients will be enrolled in the study based on the following inclusion criteria:
a)Male or Female aged 18 to 60 years (both inclusive) having Body Mass Index (BMI) at least 17 calculated as weight in kg/height in m2
b)Patients must have histopathologically/cytologically confirmed colon, colorectal or breast cancer.
c)Patients who are willing to provide written informed consent.
d)Patients who can follow the protocol requirements.
e)Patients with Dukesâ?? C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
Or
f)Patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred
Or
g)Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
h)Patients requiring a daily dose of Capecitabine mono therapy and stabilized at least for one cycle of chemotherapy on twice daily dosing at a dose of 1250 mg/m2.
i)Patients having Body Surface Area between 1.27-1.92 m2 (Both inclusive) measured as per the DuBois formula.
j)Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
k)Adequate cardiac function [Left Ventricular Ejection Fraction (LVEF) > 50 %].
l)Patient with adequate bone marrow, renal and hepatic function.
Body system and Parameters:
Bone marrow function : ANC >= 1500/mm3, Platelet count >= 100,000/mm3, Hemoglobin >= 9.0 g/dl
Renal function : Serum Creatinine < 1.5 times ULN
Hepatic function : Bilirubin <= 1.5 times ULN, ALT/AST <= 2.5 times ULN (<=5 x ULN if liver metastases present), Alkaline Phosphatase<=2.5 times ULN (<=5 x ULN if liver metastases present).
m)Patients with life expectancy of at least 3 months at the time of enrollment.
n)If the patient is of childbearing potential, she must have a negative pregnancy test at screening. (Women with childbearing potential will be advised to take adequate precautions to prevent pregnancy).
o)Cancer patients should preferably be on monotherapy. However, cancer patients receiving concomitant drug(s) can be enrolled, provided concomitant medication should be same for all study periods or presence of documentary evidence of no PK interaction with study drug.
p)In case of female patient, the urine pregnancy test at day 0 must be negative.
q)Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or post menopausal for at least 12 consecutive months, 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 Or till next chemotherapy cycle (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile sexual partner [at least6 months prior to Study drug administration]). Cessation of birth control after this point should be discussed with a responsible physician.
r)In case of male patients: Either partner or patient must use an
The patients will be excluded from the study based on the following exclusion criteria:
a)History of severe and unexpected reactions to fluoropyrimidine therapy
b)Hypersensitivity to Capecitabine or to any of the excipients or fluorouracil
c)In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity
d)During pregnancy and lactation
e)In patients with severe leukopenia, neutropenia, or thrombocytopenia,
f)In patients with severe hepatic impairment
g)In patients with severe renal impairment (Creatinine clearance below 30 ml/min),
h)If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.
i)Known hypersensitivity to Ondansetron.
j)Serious underlying diseases or disorder and complications that may interfere for assessment of the efficacy and safety of the study drug as per the discretion of the Investigator.
k)Presence of any uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
l)Severe liver and kidney diseases.
m)Any clinically significant abnormal laboratory parameter evaluated during screening.
n)A positive test result for HIV antibody.
o)Patient with chronic hepatitis (positive for Hepatitis B or C) or active autoimmune disorders.
p)Participation in any other clinical study within three months prior to randomization visit.
q)Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of study drug for the current study.
r)Patients who are having the difficulties in oral administration of study drug.
s)Patients taking any of the Cytochrome P450 2C9 substrates.
t)History of drug/alcohol addiction
u)Known brain metastasis
v)Presence of active infections
w)Any of the following cardiac conditions:
oUnstable angina
oMyocardial infarction within the past 6 months
oNYHA (New York Heart Association) class II-IV heart failure
oSevere uncontrolled ventricular arrhythmias
oClinically significant pericardial disease
oElectrocardiographic evidence of acute ischemic or active conduction system abnormalities
oAny other cardiac illness that could lead to a safety risk to the patient in case of enrolment in the study
x)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.
y)Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
z)Patient receiving the below mentioned list of medication during the study period.
Contradicated by XELODA®Prescribing Information - Analgesics/
Antipyretics - Others
1.Phenytoin - Diclofenac â?? Tamoxifen
2.Antacids (Aluminium hydroxide and magnesium hydroxide) â?? Ibuprofen â?? Torsemide
3.Leucovorin (Folinic acid) â?? lornoxicam â?? Luconazole
4.Sorivudine and analogues such as brivudine â?? Meloxicam â?? Amiodarone
5.Allopurinol - S-naproxen â?? fenofibrate
6.Warfarin â?? Piroxicam â?? fluvastatin
7.Antipsychitics/Antidepressants â?? Suprofen â?? Fluvoxamine
8.Amitriptyline â?? Celecoxib â?? Isoniazi
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the bioequivalence of Capecitabine Film Coated Tablets 500mg of Shilpa Medicare Limited, India with Xeloda® (Capecitabine) Tablets 500mg marketed by Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom, following a single oral 2000mg (4x500mg) dose administration in adult human cancer patients under fed conditionsTimepoint: Pre dose and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 7, and 8 hrs following drug administration in each period.
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of Patients.Timepoint: NA