| CTRI Number |
CTRI/2013/08/003922 [Registered on: 27/08/2013] Trial Registered Prospectively |
| Last Modified On: |
10/12/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
A RANDOMIZED, TWO TREATMENT, FOUR PERIOD, TWO SEQUENCE, SINGLE DOSE, REPLICATED CROSSOVER, BIOEQUIVALENCE STUDY 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
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CPB_500T_IR_3602_12; Ver:00 and Ammend: 01 Dt: 29 April 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Khanna |
| Designation |
Medical Advisor |
| Affiliation |
Sun Pharmaceutical Industries Ltd. |
| Address |
Tandalja
Vadodara
Vadodara
GUJARAT
390 020
India |
| Phone |
91-265-2350789 |
| Fax |
91-265-2354897 |
| Email |
Aman.Khanna@sunpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aman Khanna |
| Designation |
Medical Advisor |
| Affiliation |
Sun Pharmaceutical Industries Ltd. |
| Address |
Tandalja
Vadodara
Vadodara
GUJARAT
390 020
India |
| Phone |
91-265-2350789 |
| Fax |
91-265-2354897 |
| Email |
Aman.Khanna@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aman Khanna |
| Designation |
Medical Advisor |
| Affiliation |
Sun Pharmaceutical Industries Ltd. |
| Address |
Tandalja
Vadodara
Vadodara
GUJARAT
390 020
India |
| Phone |
91-265-2350789 |
| Fax |
91-265-2354897 |
| Email |
Aman.Khanna@sunpharma.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Limited. Tandalja, Vadodara-390020 Phone No.: 912656615500
Fax: 912652394897
|
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd |
| Address |
Acme Plaza, Andheri East,
Andheri -Kurla Road,
Mumbai – 400 059 (India)
Tel: 91-22-66969699
Fax: 91-22-8212010.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr J Jebasingh |
ASIRVATHAM SPECIALITY HOSPITAL - MADURAI |
Asirvatham Speciality Hospital,
 22, Rajaji Street,
 Gandhi Nagar,
 Madurai – 625020, Tamil Nadu
Consulting room no: 207
Madurai
TAMIL NADU |
9442619775
0452-3061971
jjebasingh@gmail.com |
| Dr KS Kirushna Kumar |
MEENAKSHI MISSION HOSPITAL - MADURAI |
Meenakshi Mission Hospital & Research Centre
Lake Area, Melur Road,
 Madurai-625107
Consulting room no: 105
Madurai
TAMIL NADU |
9841022366
0452-2586353
drkskk@yahoo.com |
| Dr HM Yathish kumar |
NRR HOSPITAL - BANGALORE |
NRR Hospital,
# 3 & 3A Hesarghatta Main road,
 Near Janapriya apartment,
 Chikkasandra,
(Near Chikkabanavara Railway Station)
 Bangalore -560 090
Consulting room no: 210
Bangalore
KARNATAKA |
9880462912
080-28374117
dryathish@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Asirvatham Speciality Hospital, Madurai, Dr J Jebasingh |
Approved |
| Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre, Madurai Dr K S Kirushna Kumar |
Approved |
| Institutional Ethics Committee of NRR Hospital- Bangalore, Dr. H M Yathish Kumar |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dukes’ C colon cancer, metastatic colorectal carcinoma, metastatic breast cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capecitabine 500 mg Tablet of Sun
Pharmaceutical Industries Limited, India
|
Single Oral Dose |
| Comparator Agent |
PrXeloda® (Capecitabine) 500 mg Tablet of
Hoffmann-La Roche Limited, 2455 Meadowpine Blvd, Mississauga,
Ontario, L5N 6L7
|
Single Oral Dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
ii. Subjects between 18 to 60 years of age (both inclusive).
iii. 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.
iv. 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.
v. Patients who are taking Capecitabine as first-line treatment for metastatic colorectal
carcinoma when treatment with fluoropyrimidine therapy alone is preferred.
vi. 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).
vii. Patients should not take any adjuvant chemotherapeutic agent except capecitabine throughout
the study and 4 weeks before the study.
viii. Patients whose life expectancy of greater than or equal to 6 months.
ix. Patients having histologically proven Cancer.
x. Patients with Performance ≤ 2 on the ECOG performance scale .
xi. 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.
xiii. 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).
|
|
| ExclusionCriteria |
| Details |
1. History or presence of significant:
i. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Capecitabine
and/or any related compounds etc.
ii. 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.
iii. Patient having cardiovascular (including coronary artery disease) & pulmonary disorder.
iv. Cancer patients with a prior history of coronary artery disease, receiving concomitant therapy of
warfarin.
v. Presence of infections which reduce life expectancy.
vi. Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within
past one year.
vii. Patient having clinical evidence of brain metastasis.
viii. Undergoing concomitant oncologic treatment.
ix. Smoking or consumption of tobacco products.
x. History of difficulty in swallowing or coming for follow up.
xi. Clinically significant illness (except Dukes’ C colon cancer/metastatic colorectal
carcinoma/metastatic breast cancer) within 4 weeks before the start of the study.
xii. Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks
preceding the study.
xiii. Female subject who is pregnant, lactating or likely to become pregnant or have a positive
pregnancy test at screening and prior to check in.
xiv. 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.
xvi. 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.
4. 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.
iii. Pulse rate below 60/min. or above 100/min.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
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.
|
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
|
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |