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CTRI Number  CTRI/2024/05/068024 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 06/04/2026
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study   - 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Bioequivalence Study of Capecitabine 500 mg with Xeloda 500 mg in Adult Cancer Patients Under Fed Condition  
Scientific Title of Study
Modification(s)  		 A Randomized Open label Single Dose Two Treatment Three Period Three Sequence Partial Replicate Crossover Multicentre Bioequivalence Study of Capecitabine Biopharm 500 mg film coated Tablets (Manufactured by Profam Algeria for Biopharm SPA Algeria) with Xeloda® 500 mg Film Coated Tablets Capecitabine (Manufacturer Excella GmbH and Co KG Germany and Marketing Authorisation Holder CHEPLAPHARM Arzneimittel GmbH Germany in Adult Cancer Patients Under Fed Conditions 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
002/ACRS/CAPA/2023/042-23 2.0 Dated 14 AUG 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Pranjal Ausekar 
Designation  Managing Director-Clinical Operations 
Affiliation  Ardent Clinical Research Services 
Address  Office No 302 303 level 3 Nyati unitree West wing Yerwada

Pune
MAHARASHTRA
411006
India 
Phone  75507779562  
Fax    
Email  pranjal@ardent-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Chandu Devanpally  
Designation  Founder & Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Office No 302 303 level 3 Nyati unitree West wing Yerwada

Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax    
Email  cdevanpally@ardent-cro.com  
 
Details of Contact Person
Public Query  
Name  Mr Chandu Devanpally  
Designation  Founder & Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Office No 302 303 level-3 Nyati unitree West wing Yerwada

Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax  -  
Email  cdevanpally@ardent-cro.com  
 
Source of Monetary or Material Support  
Plot No 26 27 1st Floor Techno Cooperative Industrial Estate Balanagar Hyderabad Telangana 500037 India 
 
Primary Sponsor  
Name  BIOPHARM SPA 
Address  BIOPHARM SPA 62 Industrial zone, Oued Smar Algiers Algeria-16000 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Ardent Clinical Research Services  Ardent Clinical research services 154 155 level 1 Connaught place bund garden road Pune India 411001 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K V krishnamani  American Oncology Institute  First Floor 1 100 1 CCH Citizens Hospital Rd near Aparna Sarovar Nallagandla Telangana 500019
Hyderabad
TELANGANA 		 9393635072
-
kkvkmani@gmail.com 
Dr velavan  Erode Cancer Care Centre  Department of Oncology Ground Floor Room No 24 SH-96 1/393 velavan nagar perundurai road Thindal TamilNadu 638012 Inida
Erode
TAMIL NADU 		 9842334222
-
kvels@rediffmail.com 
Dr Govindaraj Ganesan  Harshamitra super speciality cancer centre and research institute  Oncology Department Ground Floor Room No 2 Surgical Oncology division Harshamitra Super Speciality Cancer Care And Research Institute No 101/4A Mathur Panchayat Road Madurai Highway Nagamangalam Trichy 620012
Madurai
TAMIL NADU 		 9844685166
-
govindarajganesan@gmail.com 
Dr Vaibhav Amale  Horizon Multispeciality Hospital  Clinical Research Department 1st floor Room No 1 Medical oncology division Horizon Multispeciality Hospital District hospital road ganesh nagar patrakar nagar sangli 416416
Sangli
MAHARASHTRA 		 8390913771
-
vai7444@gmail.com 
Dr Raza Mohd Waseem  JK Cancer Institute  Department of Radiotherapy Ground Floor Room No 13 Radiotherapy Division J K Cancer Institute Kanpur bear rawatpur crossing uttarpradesh 208002
Kanpur Dehat
UTTAR PRADESH 		 9868996848
-
waseem.drraza000@gmail.com 
Dr Vilas L  K R hospital Mysore medical college and research Institute  Room No 01 Jayadeva Block KR Hospital 1st Floor Oncology Ward Opd No 23 Department of Oncology K R Hospital Mysore Medical College and Research Institute irwin road myore 570001
Mysore
KARNATAKA 		 9663099774
-
vikilaxman@gmail.com 
Dr Neve Rakesh Suresh  Lifepoint Multispeciality Hospital  Lifepoint Multispeciality Hospital 3rd Floor Clinical Research Department 145/1 Mumbai Banglore Highway Near Hotel Sayaji Wakad Pune 411057 Maharashtra India
Pune
MAHARASHTRA 		 09881143140
-
rakeshneve05@gmail.com 
Dr Smitha Saldanha   Nano Hospital  Fourth floor Clinical research unit 79 Sir M Visveswaraya road Near Arekere Sai Baba temple Off Bannergatta road Bangalore 560076
Bangalore
KARNATAKA 		 09844685166
-
saldanhasmitha@gmail.com 
Dr Nikhil Shirsi  Sangvi Research Multispeciality Hospital  5th Floor Clinical Research Department Sangvi Multispeciality Hospital S No 71/1/2/189 C S no 2387 Krushna Chowk New Sangvi
Pune
MAHARASHTRA 		 7835826155
-
drshirsi.sangvihospital@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Institutional Ethics Committee Harshamitra Superspeciality Cancer Centre  Approved 
Citizens institutional ethics committee  Approved 
Ethics Committee GSVM Medical College  Submittted/Under Review 
Ethics committee Horizon Multispecialty Hospital  Approved 
Institutional Ethics Committee Erode Cancer Centre  Approved 
Institutional Ethics committee mysore medical college and research institute  Approved 
Institutional ethics committee sangvi multispeciality hospital  Approved 
lifepoint reasearch Ethics commitee  Approved 
Sri Durgamba Independent ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R971||Elevated cancer antigen 125 [CA 125],  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Capecitabine 500 mg  Capecitabine 500 mg film coated Tablets Manufactured by Profam Algeria for Biopharm SPA Algeria for oral administration 03 tablets multiples of 500 mg tablets under fed condition Single oral dose (1250mg/m2) will be given in respective period as per randomization sequence for 01 day out of 03 days of treatment period intervention(Capecitabine 500 mg) product will be administered  
Comparator Agent  Xeloda® 500 mg  Xeloda® 500 mg Film Coated Tablets Capecitabine (Manufacturer Excella GmbH & Co KG Germany and Marketing Authorisation Holder CHEPLAPHARM Arzneimittel GmbH Germany) for oral administration 03 multiples of 500 mg tablets under fed condition. Single oral dose (1250mg/m2) will be given in respective period as per the randomization sequence for 02 days Comparator (Xeloda® 500 mg) product will be administered out of 03 days of treatment period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Males or non-pregnant or non-lactating females of age between greater than 18 to 60 years (both inclusive)
2 Patients in whom capecitabine therapy is indicated Dukes’ C colon cancer Single agent as adjuvant therapy or Metastatic colorectal cancer First line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred or
Metastatic Breast Cancer As monotherapy in patients resistant to both paclitaxel and an anthracycline containing regimen
3 Patients already receiving a stable twice-daily dosing regimen of capecitabine (1250 mg/m2 twice daily equivalent to 2500 mg/m2 total daily dose for two-weeks followed by a one-week
rest period given as three-week cycles)
4 Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
5 Patients with life expectancy of at least 3 months
6 Adequate cardiac function [left ventricular ejection fraction LVEF ≥ 50 %
7 Patient with adequate
- Bone marrow (ANC ≥ 1500/mm3, Platelet count ≥
100,000/mm3 Hemoglobin ≥ 9.0 g/dL)
- Renal (Serum Creatinine ≤ 1.5 times ULN and creatinine clearance ≥ 51 to 80 mL/min [Cockroft and Gault]) and
- Hepatic function (Bilirubin ≤ 1.5 times ULN, ALT/AST ≤ 3 times ULN (≤ 5 x ULN if liver metastases present))
8 Patients should be non-smokers
9 Patient willing and able to give written informed consent for participation in the study and comply with the study protocol
10 No persistent clinically significant toxicities from prior medications at screening.
11 Females of child-bearing potential must agree to use an acceptable method of birth control such as sexual abstinence or at least reliable modes of contraception from screening until 3 months after last dose of study drug
[Note Use of hormonal contraception(pills/hormonal
intrauterine device etc) is not allowed
OR Post-menopausal females defined as at least 12 consecutive months with no menses without an alternative medical cause
OR surgically sterilized females with documented evidence of hysterectomy/bilateral salpingectomy/bilateral oophorectomy
12 Male patient must agree to use an acceptable method of birth control such as sexual abstinence or barrier method of contraception (condom) from screening until 3 months after last dose of study drug Subject agrees to accept the risk that
pregnancy in female partner could still result despite using birth control devices
13 Cancer patients should preferably be on monotherapy However cancer patients receiving concomitant drug(s) are allowed to participate provided
- The concomitant medication is the same for all the study
period and clearly documented.
- Patients do not require any change in their concurrent
medications during the study period 
 
ExclusionCriteria 
Details  1 Patients with known hypersensitivity to capecitabine or to any of its components of formulation or 5-fluorouracil
2 Patients with known DPD (Dihydro pyrimidine
Dehydrogenase) deficiency
3 Prior unanticipated severe reaction to Capecitabine or metabolites and to fluoropyrimidine therapy
4 Patients with a prior history of coronary artery disease
5 Patients who are on oral-coumarin derivative anticoagulants such as warfarin or phenprocoumon at the time of screening or anticipated use of these drugs during the study period[If the
subject was on any of these drugs before screening a wash out
19 Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial period of at least 5 half-lives must have elapsed since the last
dose of such drug
6 Patients receiving concomitant therapy of Phenytoin Leucovorin and CYP2C9 substrates at the time of screening or anticipated use of these drugs during the study period [If the
subject was on any of these drugs before screening a wash out period of at least 5 half-lives must have elapsed since the last dose of such drug] Presence of active infections
7 Patients with known brain metastasis.
8 Pre-existing motor or sensory neurotoxicity of severity ≥ 2 by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) criteria
9 Use of any recreational drugs or history of drug addiction
10 Have a history of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to Screening
11 Consumption of grapefruit grapefruit-like or grapefruit containing products within 7 days prior to study drug administration
12 Use of enzyme modifying drugs within 30 days prior to study drug administration They can be allowed depending on Principal Investigator’s discretion if they are kept constant in
the last 30 days and are expected to remain constant during the study period
13 Major surgery to the gastrointestinal tract, liver or kidney within 3 months prior to study entry which may affect the pharmacokinetics of capecitabine
14 History of difficulty in swallowing or any gastrointestinal disease e.g. ulcerative colitis ulcerative stomatitis malabsorption syndrome and/or lack of physical integrity of the
upper intestinal tract which could affect drug absorption
15 History or presence of cardiac disease including myocardial infarction unstable angina coronary artery disease heart failure dysrhythmias cardiomyopathy significant pericardial
disease or any other cardiac illness that could affect patient safety
16 Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
17 History or evidence of uncontrolled coagulopathy.
18 Patients with severe hepatic or renal impairment
19 Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial
20 Patients who have had experienced a severe mucocutaneous reaction during prior capecitabine treatment
21 History of difficulty with donating blood or difficulty in accessibility of veins or
intolerance to venepuncture or patients who have bled more than 300 mL in the past 3 months
22 Participation in any clinical trial of investigational drugs or devices in the past 3
months
23 Any significant disease or condition of haemopoietic gastrointestinal renal hepatic
cardiovascular respiratory central nervous system diabetes psychosis or any other body system which might compromise patient safety or affect study results
24 Patients with positive alcohol breath test or positive urine screen test for drugs of
abuse (Amphetamines, Morphine Benzodiazepines Marijuana, Cocaine and Barbiturates) at Period I hospitalization
25 A positive screen test for HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV)
virus
26 History of allergy to heparin or any food allergy that in the opinion of the Investigator
could contraindicate the patient’s participation in study
27 Any other condition that in the investigator’s judgment might compromise patient safety or affect study results 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Bioequivalence of two formulations (Test vs Reference) in
relation to the
2 Rate of absorption
3 Extent of absorption
Pharmacokinetic parameters Cmax AUC0-t
 		 Period 1 to Period 3 (Total 3 days) 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events laboratory abnormalities will be monitored for safety
Assessment of the other pharmacokinetic parameters AUC0-∞ Tmax Kel t1/2 and
Residual area 		 Baseline to End of the study 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/06/2024 
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)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
A randomized open-label single-dose two-treatment three-sequence three-period partial replicate crossover bioequivalence study. Patients with Dukes’ C colon cancer metastatic colorectal cancer or metastatic breast cancer will be enrolled in the study Screening procedure will include collection of demography data, medical history physical examination, vital signs (pulse, blood pressure, respiratory rate and oral temperature), 12 lead electrocardiogram (ECG), chest X-ray, hematology, biochemistry, serology, urine pregnancy test (for female patients of childbearing potential), urinalysis and ECOG performance evaluation. During this three-period study, all patients will receive a single dose of the test product once and single dose of the reference product twice (reference replicate study design) under fed conditions. Each patient will be randomized to receive test and reference products as per any one of the three sequences according to the randomization schedule In each period, following an overnight fast of at least 10 hours, patients will be given high fat high calorie breakfast approximately 800-1000 Kcal) 30 minutes before investigational product administration. Patients will consume this breakfast in 30 minutes or less and the investigational product will be administered 30 minutes after start of the breakfast. Compliance to high-fat high calorie breakfast will be assessed by the site personnel and
will be documented. Patients will take 03 tablets of either the investigational product or reference administered at once with 200 mL of water after high fat and high calorie breakfast. Investigational
products (Test or Reference) must be swallowed whole and must not be chewed, crushed or divided. This activity will be followed by mouth and hand check of the patients to assess compliance to dosing.
The dose will be calculated based upon body surface area of patients. The recommended dose of capecitabine is 1250 mg/m2 administered orally twice daily (equivalent to 2500 mg/m2 total daily dose). The patients will be administered either the reference drug or the test drug only as the first morning dose. On Day 1 (Period I), patients will receive the morning dose of capecitabine as IP (test or reference). The remaining balance daily dose of the day (evening dose) will be administered after 12 hours of the morning dose as non IP. The evening dose will be calculated as ‘Total daily dose minus Morning dose’. On Day 2 (Period II) and Day 3 (Period III), patients will be crossed over to receive either test or reference products as per the randomization schedule. The morning dose (IP) and evening dose (non IP) of capecitabine will remain the same in all three study periods. From Day 4 of the cycle onwards, the patient will continue to receive his/ her twice-daily stable dose as per the schedule determined by Investigator. A washout period of at least 24 hours will be given between each dosing (Test or Reference)
 
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