CTRI/2025/08/092830 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On:
29/05/2026
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Bioequivalence Study of Olaparib Tablets 150 mg of in Adult Participants with Cancer and Stable on Olaparib Therapy.
Scientific Title of Study
A Double-Blind, Randomized, Four-Period, Two-Treatment, Two-Sequence, Crossover, Multicenter, Multiple-Dose, Steady State Bioequivalence Study of Olaparib Tablets 150 mg of Zydus Lifesciences Limited with PrLYNPARZA® (Olaparib) Tablets 150 mg of AstraZeneca Canada Inc., in Adult Participants with Cancer and Stable on Olaparib Therapy Under Fasting and Fed Conditions.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: C2A05538 Version: 02 Date: 04 Jun 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations, Clinical Trials
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
2717698500
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Director - Clinical Trials
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
2717698500
Fax
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Mohit Vyas
Designation
Project Manager - Clinical Trial
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
2717698500
Fax
Email
msvyas@cliantha.com
Source of Monetary or Material Support
Zydus Lifesciences Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad-382481, Gujarat, India
Primary Sponsor
Name
Zydus Lifesciences Limited
Address
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad-382481, Gujarat, India
Department of Oncology, Research Department, Surya Arcade, 2nd floor, Opposite Nimani Bus Stand, Panchvati, Nashik-422003, Maharashtra, India Nashik MAHARASHTRA
8971988085
drsonalcd@gmail.com
Dr Ravisankar A
Aster Narayanadri Hospital
Clinical Research Unit, Basement -1, SV Auto nagar, D. No. 9-100/1, Renigunta Road, Tirupati-517506, Andhra Pradesh, India Chittoor ANDHRA PRADESH
8919880170
arigela.ravisankar@gmail.com
Dr Kartikeya Jain
Bankers Superspeciality Hospital
Fourth Floor, Clinical Research Department, Division of Bankers Cardiology Pvt. Ltd., Opposite Mahalakshmi Party Plot, Tulsidham, GIDC Road, Manjalpur, Vadodara-390011, Gujarat, India Vadodara GUJARAT
9427432642
drkartikeyajain@gmail.com
Dr Ashwin Arvind Rajbhoj
Care Multispeciality Hospital
Research Department, Oncology Department, Second floor, Kolte Arcade, Pune-Nagar Road, Wagholi, Near Bazar Tal. Haveli, Pune-412207, Maharashtra, India Pune MAHARASHTRA
8793398680
ash127win@gmail.com
Dr Akash Tiwari
DNS Hospitals Pvt. Ltd.
Room No. 208, Clinical Research Room, Second Floor, 14 Anoop Nagar, LIG Square, AB Road, Indore-452008, Madhya Pradesh, India Indore MADHYA PRADESH
9968721696
akash07tiwari@gmail.com
Dr Velavan Kandappan
Erode Cancer Centre
Department of Radiation Oncology, Clinical Research Division, Ground Floor, SH 1/393, Velavan Nagar, Perundurai Road, Thindal, Erode-638012, Tamil Nadu, India Erode TAMIL NADU
9842822443
kvels@rediffmail.com
Dr Lakshmi Priyadarshini K
HCG City Cancer Center
Department of Oncology, Clinical Research Department, Second Floor, 33-25-33, CH Venkata, Gopala Krishnaiah Street, Suryarao pet, Guntur, Vijayawada-520002, Andhra Pradesh, India Krishna ANDHRA PRADESH
9966030988
priyadarshini006@gmail.com
Dr Saptarshi Ghosh
Hope & Heal Cancer Hospital and Research Center
Clinical Research Department, First floor, Department of Radiation Oncology, Jatiakhali, Fulbari, Binnaguri, Siliguri, Jalpaiguri-734015, West Bengal, India Jalpaiguri WEST BENGAL
8106572241
drsaptarshi10@gmail.com
Dr Amale Vaibhav Baburao
Horizon Multispeciality Hospital
First Floor, Clinical Research Department, S. No. 90/2B/1A/2A/1, Plot No. 1+3, Dhamani Road, Sangli-416416, Maharashtra, India Sangli MAHARASHTRA
8390913771
vai7444@gmail.com
Dr Sonawane Satish Ramkrishna
Maccare Super Speciality Hospital
Department of Oncology, Bishop Lloyd Colony, Behind Zopadi Canteen, Opposite Saint Monika D.Ed. College, Savedi, Ahilya Nagar, Ahmednagar-414003, Maharashtra, India Ahmadnagar MAHARASHTRA
9730099999
satishujjwal@yahoo.com
Dr Venugopal Arroju
Pi Health Cancer Hospitals
Survey No-110, Phase IV, Plot 184, HIG-B, DLF Road, Gachibowli, Serilingampally Ranga Reddy, Hyderabad-500032, Telangana, India Hyderabad TELANGANA
9980707675
venugopal.arroju@picancerhospital.ai
Dr Anuj Kumar Bansal
Punjab Cancer Care and Multispeciality Hospital
Clinical Research Room, Basement -02, Z-3-03570, Goniana Road, Opposite Dayal Kidney Hospital, Near Tinkoni, Bathinda-151001, Punjab, India. Bathinda PUNJAB
8728840999
anujkumarbansal2003@gmail.com
Dr Vikas T Talreja
Regency Hospital Limited
Day Care Ward, Clinical Research Room, First Floor, Cancer and Gastro Care Centre (Tower-2), A4, Sarvodaya Nagar, Kanpur-208005, Uttar Pradesh, India Kanpur Nagar UTTAR PRADESH
9769890961
vikasttalreja@gmail.com
Dr Ghanashyam Biswas
Sparsh Hospital and Critical Care Private Limited
Department of Oncology, Clinical Research Division, Ground Floor, A/407, Back Side of Kalyan Jewelers, Saheed Nagar, Bhubaneshwar-751007, Odisha, India Khordha ORISSA
9937500878
drgbiswas@gmail.com
Dr Rakesh Taran
Taran Onco Care
Room No. 23, Clinical Research Department, Ground Floor, Oncology Department, 1, Ravindra Nagar, Near Patrakar Square, Indore-452018, Madhya Pradesh, India Indore MADHYA PRADESH
Institutional Ethics Committee, Hope and Heal Cancer Hospital and Research Centre
Approved
Institutional Ethics Committee, Maccare Hospital
Approved
Institutional Ethics Committee, Sparsh Hospitals and Critical Care Private Limited
Approved
Leelavati Ethics Committee
Approved
PI Health Ethics Committee, PI Health Cancer Hospital
Approved
Rectitude Ethics Committee, DNS Hospitals Pvt. Ltd
Approved
Rectitude Ethics Committee, DNS Hospitals Pvt. Ltd
Approved
Regency Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C50||Malignant neoplasm of breast,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Olaparib Tablets 150 mg
Dose: Olaparib tablets 150 mg (two tablets of 150 mg)
From Day 01 to Day 05 in Period-I, Day 06 to Day 10 in Period-II, Day 11 to Day 15 in Period-III and Day 16 to Day 20 in Period-IV.
Treatment Duration: Total 20 days.
Frequency: An oral dose of either the test product (two tablets of 150 mg) or reference product PrLYNPARZA® (Olaparib) Tablets 150 mg (two tablets of 150 mg) will be administered in the morning and evening, at an interval of 12 hours between the doses, i.e. twice daily (total dose: 600 mg/day)
Comparator Agent
PrLYNPARZA® (Olaparib) Tablets 150 mg
Dose: Olaparib tablets 150 mg (two tablets of 150 mg)
From Day 01 to Day 05 in Period-I, Day 06 to Day 10 in Period-II, Day 11 to Day 15 in Period-III and Day 16 to Day 20 in Period-IV.
Treatment Duration: Total 20 days.
Frequency: An oral dose of either the test product (two tablets of 150 mg) or reference product PrLYNPARZA® (Olaparib) Tablets 150 mg (two tablets of 150 mg) will be administered in the morning and evening, at an interval of 12 hours between the doses, i.e. twice daily (total dose: 600 mg/day)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or non-pregnant, non-lactating female between 18-65 years of age (both inclusive).
2. Participant with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
Note: Participants must have confirmation of germline BRCA mutation before olaparib treatment is initiated. OR Participant with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
Note: Participant with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before olaparib treatment is initiated. OR Participant with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy.
Note: Participants must have confirmation of BRCA mutation (identified by either germline or tumour testing) before olaparib treatment is initiated. OR Participant with platinum-sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Note: Platinum-sensitive relapse is defined as disease progression occurring at least 6 months following completion of platinum chemotherapy. OR Participant with deleterious or suspected deleterious gBRCAm metastatic adenocarcinoma of the pancreas whose disease has not progressed on a minimum of 16 weeks of first-line platinum-based chemotherapy.
Note: Germline BRCA mutation must be confirmed before olaparib treatment is initiated. OR Participant with deleterious or suspected deleterious germline and/or somatic BRCA or ATM mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent.
Note: BRCA or ATM mutations must be confirmed before olaparib treatment is initiated. OR In combination with abiraterone and prednisone or prednisolone for the treatment of adult participants with deleterious or suspected deleterious germline and/or somatic BRCA mutated mCRPC in whom chemotherapy is not clinically indicated
Note: BRCA mutations must be confirmed before olaparib treatment is initiated.
3. Participant with body mass index (BMI) 18.5 to 30.0 kg/m2 (both inclusive).
4. Participant with established dosing regimen who are already receiving a stable dose of olaparib tablets (2x150 mg tablets) 300 mg twice daily for at least 15 days or willing to undergo at least 15 days of stabilization period with olaparib tablets (2x150 mg tablets) 300 mg twice daily.
5. Participant with life expectancy greater than or equals to 3 months.
6. Acceptable hematology status:
a. Hemoglobin greater than or equals to 10 g/dL with no blood transfusions in the previous 28 days prior to randomization.
b. Absolute neutrophil count (ANC) greater than or equals to 1500 cells/µL.
c. Platelet count greater than or equals to 1,00,000 cells/µL.
7. Acceptable liver function:
a. Alanine aminotransferase (ALT) less than or equals to 2.5 x upper limit of normal (ULN) or less than or equals to 5 x ULN in the presence of liver metastases.
b. Aspartate aminotransferase (AST) less than or equals to 2.5 x ULN or less than or equals to 5 x ULN in the presence of liver metastases.
c. Total bilirubin less than or equals to 1.5 x Upper Limit Normal (ULN) or less than or equals to 3 x ULN in the presence of liver metastasis.
d. Alkaline phosphatase less than or equals to 2 x ULN.
8. Calculated serum creatinine clearance greater than or equals to 50 mL/min (using Cockcroft-Gault formula) which is as follows: Formula of creatinine clearance: Crcl equals to (140 - Age) x mass (Kilogram weight) / 72 x S.Cr in (mg/dl), if female x 85 percent.
9. Eastern Cooperative Oncology Group (ECOG) performance status less than or equals to 2.
10. Non-smokers and non-tobacco users (i.e., having no past history of smoking and tobacco consuming for at least one year prior to screening).
11. Male participant if sexually active with a female of child bearing potential must agree to use barrier method of contraception throughout the study period and for at least 6 months after last dose of study drug.
12. Female participant with postmenopausal status or female of child bearing potential with negative pregnancy test must agree to practice two acceptable method of contraception throughout the study period and for at least 6 months after last dose of study drug. Postmenopausal is defined by any one of the following:
a. Postmenopausal with spontaneous amenorrhea for at least one year, or
b. 6 months to 12 months of spontaneous amenorrhea with serum FSH levels greater than 40 mIU/mL.
c. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or.
d. Total hysterectomy and an absence of bleeding for at least 3 months
13. Participant willing and able to comply with the protocol requirements.
14. Participant/LAR willing to provide informed consent to participate in the study.
ExclusionCriteria
Details
1. Participant with a known hypersensitivity to olaparib or any of the excipients of the product.
2. Participant receiving any systemic chemotherapy (except abiraterone or prednisone or prednisolone), or radiotherapy within 4 weeks prior to stabilization.
3. Participant who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to randomization.
4. Participant with any ongoing toxicities (CTCAE (Common Terminology Criteria for Adverse Events) greater than or equals to grade 2), with the exception of alopecia, caused by previous cancer therapy.
5. Participant with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
6. Participant with known myelodysplastic syndrome/acute myeloid leukemia.
7. Participant with known history/ risk of venous thromboembolic events.
8. Participant with symptomatic uncontrolled brain metastases. Participant can receive stable dose of steroids before and during study as long as these were started at least 4 weeks prior to treatment. Participant with cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
9. Major surgery within 2 months of screening or not recovered from any undesirable or harmful effects of any major surgery.
10. History of other malignancies in the last 5 years (Potential participants with prior history of in situ cancer or basal or squamous cell skin cancer are eligible).
11. Current or anticipated use of any prohibited medications during study participation.
12. Concomitant use of known potent CYP3A4 (Cytochrome P4503A4) inhibitors or inducers.
13. Participant with serum positivity for Hepatitis B, C or HIV.
14. Any significant disease or condition which might compromise the haemopoeitic, gastrointestinal (e.g., pancreatitis), renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis, or any other body system.
15. Ingestion of any caffeine or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs, dietary items that have effect on P450 enzymes (e.g., pomegranate, star fruit, seville oranges) and PGP (P-Glycoprotein) efflux pump (e.g., St. Johns wort) within 48 hours prior to randomization.
16. History of drug dependence, history of alcoholism [more than 2 drinks per day, 1 drink is defined as 360 mL of beer, 240 mL of malt liquor, 150 mL of wine and 45 mL of distilled spirits (gin, rum, vodka, whiskey, etc.)] in the past 1 years prior to screening.
17. Use of grapefruit and grapefruit containing products within 07 days prior to randomization.
18. Participation in any investigational drug study within 30 days prior to screening.
19. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days.
20. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
21. Participant who is unable to swallow orally administered medication and participant with gastrointestinal disorders likely to interfere with absorption of the study medication.
22. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the participants participation in this study.
23. Any other condition or any clinically significant abnormalities in ECG or laboratory parameters that, in the investigators judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
24. Institutionalized participant.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Cmaxss, Cminss and AUC0-tauss
3 weeks
Secondary Outcome
Outcome
TimePoints
Cpdss and Tmaxss
Safety endpoints: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE).
3 Weeks
Target Sample Size
Total Sample Size="48" Sample Size from India="48" Final Enrollment numbers achieved (Total)= "48" Final Enrollment numbers achieved (India)="48"
Phase of Trial
N/A
Date of First Enrollment (India)
26/09/2025
Date of Study Completion (India)
26/03/2026
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)
Not Applicable
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
This is a randomized, double-blind,
four-period, two-treatment, two-sequence, crossover, multicenter,
multiple-dose, steady state bioequivalence study.
The Zydus Lifesciences Limited, India has developed Olaparib
Tablets 150 mg and is seeking approval
for its generic drug application in Health Canada. This formulation contains
the same active pharmaceutical ingredient (API) as the existing medication PrLYNPARZA®
(Olaparib) Tablets 150 mg of AstraZeneca Canada Inc. necessitating a demonstration
of bioequivalence to the reference product.
This pharmacokinetic study aims to compare multiple-dose
PK parameters and safety of test formulation Olaparib Tablets 150 mg of Zydus
Lifesciences Limited, India with PrLYNPARZA® Olaparib Tablets 150 mg (2*150 mg tablets) of
AstraZeneca Canada Inc., in adult participants with cancer and stable on olaparib therapy under
fasting and fed condition.