| CTRI Number |
CTRI/2026/01/100286 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| 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 Olaparib tablets 150 mg in patients with ovarian or breast or prostate cancer. |
|
Scientific Title of Study
|
A randomized, open label, multi-centre, two-treatment, four-period, two-sequence, multiple dose, steady-state, full replicate, crossover, bioequivalence study of Olaparib tablets 150 mg (Sandoz Private Limited) and Lynparza tablets (Olaparib) 150 mg (AstraZeneca do Brasil Ltda) in participants with ovarian or breast or prostate cancer under fasting condition. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 25-VIN-0407 Version 01 dated 07 Oct 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Patel |
| Designation |
Head - Clinical Operations |
| Affiliation |
Veeda Clinical research Limited |
| Address |
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M.,Ambawadi,
Ahmadabad
Ahmadabad
GUJARAT
380015
Ahmadabad
GUJARAT
380015
India |
| Phone |
8308843660 |
| Fax |
|
| Email |
Rakesh.Patel@veedalifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Alamchandani |
| Designation |
General Manager |
| Affiliation |
Veeda Clinical research Limited |
| Address |
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M.,Ambawadi,
Ahmadabad
Ahmadabad
GUJARAT
380015
Ahmadabad
GUJARAT
380015
India |
| Phone |
9687306158 |
| Fax |
|
| Email |
Ravi.A1950@veedalifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Alamchandani |
| Designation |
General Manager |
| Affiliation |
Veeda Clinical research Limited |
| Address |
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M.,Ambawadi,
Ahmadabad
Ahmadabad
GUJARAT
380015
Ahmadabad
GUJARAT
380015
India |
| Phone |
9687306158 |
| Fax |
|
| Email |
Ravi.A1950@veedalifesciences.com |
|
|
Source of Monetary or Material Support
|
| Lek Pharmaceuticals d.d., Verovskova ulica 57, 1526 Ljubljana, Slovenia
|
|
|
Primary Sponsor
|
| Name |
Lek Pharmaceuticals d.d. |
| Address |
Verovskova ulica 57
1526 Ljubljana
Slovenia |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Veeda Clinical Research Ltd |
Shivalik Plaza, Near I.I.M., Ambawadi
Ahmedabad 380 015, Gujarat, India
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Velavan |
Erode cancer Hospital |
Radiation Oncology department, Thindal
Erode
TAMIL NADU |
9842822443
kvels@rediffmail.com |
| Dr Rajnish Nagarkar |
HCG Manavta Cancer Centre |
Surgical Oncology department, Behind Shivang Auto, Mumbai Naka
Nashik
MAHARASHTRA |
9823061929
drraj@manavtacancercentre.com |
| Dr Nikhil Shirsi |
Indrayani Hospital & Cancer Institute |
Alandi Road Alandi, Devachi, Charholi Budruk
Pune
MAHARASHTRA |
8007167716
asmapathan124@gmail.com |
| Dr Koranne Ameya Anil |
Kailash Cancer Hospital and Research Centre |
Department of Medical Oncology, Goraj,Muni seva Ashram,Waghodiya
Vadodara
GUJARAT |
7874361520
ameya.koranne@greenashram.org |
| Dr P K Chaitanya |
MNJ institute of oncology and regional cancer centre |
Department of Medical Oncology, New building (Aurobindo block), Red Hills
Hyderabad
TELANGANA |
8897199994
mnjorccchaitanya@gmail.com |
| Dr Anil Kumar MR |
Oncoville Cancer Hospital and Research Centre |
Centre No. 4, 80 ft. road, 7th Block, Nagarbhavi, 2nd stage
Bangalore
KARNATAKA |
9739808502
dranil.onco@gmail.com |
| Dr Anshul Agarwal |
PP Maniya Hospital Private Limited |
Medical Oncology department, Near Mamata Park Society-1, Opp Dharuka College, Varachha main road, Kapodra
Surat
GUJARAT |
8657068668
Anshul.onco@gmail.com |
| Dr Nirali Trivedi |
Shankus Hospital Pvt Ltd |
Oncology Department, Behind Divine Child School, Near shankus water park, Mehasana-Palanpur Highway
Mahesana
GUJARAT |
8980008109
dr.nirali@shankushospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| IEC Oncoville Cancer Hospital and Research Centre |
Approved |
| IEC shankus hospital |
Approved |
| IEC, KCHRC |
Approved |
| IEC- Erode Cancer Centre |
Approved |
| Manavata Clinical Research Institute Ethics Committee |
Submittted/Under Review |
| MNJIO and RCC Ethics Committee |
Submittted/Under Review |
| Narsimha Saraswati Medical Foundation Ethics Committee |
Submittted/Under Review |
| PP Maniya Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C61||Malignant neoplasm of prostate, (3) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lynparza tablets (Olaparib) 150 mg of AstraZeneca do Brasil Ltda |
150 mg film coated tablet, twice a day for 14 days |
| Intervention |
Olaparib tablets 150 mg (Sandoz Private Limited) |
150 mg film coated tablet, twice a day for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with already diagnosed or known cases of -
Ovarian Cancer:
Maintenance treatment of adult participants with ovarian carcinoma (including fallopian tube or primary peritoneal carcinoma), newly diagnosed, high-grade - grade 2 or higher advanced, with BRCA mutation, who respond - complete or partial response to first line, platinum based chemotherapy.
OR
Maintenance treatment of adult participants with serous ovarian carcinoma-including fallopian tube or primary peritoneal or endometrioid carcinoma, high grade - grade 2 or higher, relapsed, platinum-sensitive and responsive - complete or partial response to platinum-based chemotherapy.
OR
Breast Cancer:
Adjuvant treatment of adult participants with HER2-negative high-risk early breast cancer with BRCA mutation, who were previously treated with neoadjuvant or adjuvant chemotherapy.
OR
Treatment of adult participants with HER2-negative, metastatic breast cancer with a germline mutation in BRCA gene - pathogenic or suspected pathogenic previously treated with chemotherapy. These participants may have received chemotherapy in a neoadjuvant, adjuvant or metastatic setting. Participants with hormone receptor-positive breast cancer, must have been treated with prior endocrine therapy or be considered unsuitable for endocrine therapy.
OR
Prostate cancer:
Monotherapy for the treatment of adult participants with metastatic castration-resistant prostate cancer and BRCA1/2 mutation involved in homologous recombination - germline and/or somatic, whose disease progressed after prior treatment with a new hormonal agent.
2. Non-smoking, non-pregnant, non-lactating participant greater than or 18 years of age with a BMI in the range of 18.50 to 30.00 kg per m sqaure- both inclusive.
3. Able to give written informed consent for participation in the trial and willing to adhere to protocol requirements.
4. Participant having an estimated survival of at least 3 months.
5. Eastern Cooperative Oncology Group performance status of 0-2.
6. Adequate organ and bone marrow function based upon the laboratory criteria at the time of eligibility assessment.
7. Absence of blood transfusion in the 28 days prior to randomization.
8. Women of non-child bearing potential with documented evidence of hysterectomy or bilateral oophorectomy at least 6 months prior to IMP administration or postmenopausal -defined as 12 consecutive months of spontaneous amenorrhea without medical explanation for at least one year.
OR
Women of child bearing potential must have negative pregnancy test at screening visit and before randomization and must agree to use an effective method of avoiding pregnancy - oral, transdermal or implanted hormonal contraceptives in conjunction with a secondary method; non-hormonal intrauterine device + condom or diaphragm with spermicide; condom + diaphragm with spermicide; absolute sexual abstinence or sterile at least 6 months prior to IMP administration - sexual partner for at least 4 weeks or 3 months for oral contraceptives prior to stabilization medication/IMP administration, during the study and for 6 months after the last dose of IMP.
9. Male participants must agree to not donate sperm and to use a condom when having sexual intercourse with a female partner who is pregnant or of child bearing potential from the first dose of stabilization medication or IMP, during the study and for 3 months after the last dose of IMP. Their female partners of child bearing potential should also use oral, transdermal or implanted hormonal contraceptives, non-hormonal intrauterine device, or diaphragm with spermicide. |
|
| ExclusionCriteria |
| Details |
Participants who meet any of the following criteria at screening will not be enrolled in the study:
1. History of known hypersensitivity to Olaparib or its components which, in the opinion of the Investigator, would compromise the safety of the participant or the results of the study.
2. Participants found positive for HIV, Anti-HBc IgM, Syphilis, Hepatitis B surface antigen or Hepatitis C antibody at screening.
3. Have ongoing clinically significant adverse events due to prior treatments administered, as determined by the investigator.
4. Participants with Pneumonitis.
5. Participants with severe hepatic impairment - Child Pugh classification category C, moderate renal impairment and severe renal impairment or end-stage renal disease.
6. In the opinion of the Investigator, the participant will not be compliant with the requirements of the study procedures.
7. Blood loss of 1 unit or 350 ml within 90 days prior to first dosing in Period I for the current study.
8. Usage of strong and moderate CYP3A inhibitors e.g., cimetidine, ciprofloxacin, grapefruit juice or strong and moderate CYP3A inducers e.g., carbamazepine, phenytoin, St. John’s Wort, rifampicin within 30 days prior to first dosing in Period I refer annexure XIII for full list of prohibited medications.
9. Pregnant or lactating females.
10. History or presence of alcoholism or drug abuse.
11. Difficulty in swallowing tablets. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the pharmacokinetics and establish the bioequivalence between Lynparza (Olaparib) tablets 150 mg Sandoz Private Limited – test formulation and Lynparza tablets (Olaparib) 150 mg of AstraZeneca do Brasil Ltda - reference product in participants with ovarian or breast or prostate cancer under fasting condition. |
Pre-dose on Day 1, 4, 5, 6, 7, 11, 12, 13 and 14
Post dose on Day 6, 7, 13 and 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the adverse events of participants and to assess safety of each of the two formulations. |
Adverse event monitoring and Safety assessment of the test or reference product will be done throughout the study duration |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 two-treatment, four-period, two-sequence, multiple dose, steady-state, full replicate, crossover, bioequivalence study of Olaparib tablets 150 mg in participants with ovarian or breast or prostate cancer under fasting condition. Patients will be enrolled after providing written informed consent and treatments will be allocated to patient by carrying out randomization using statistical techniques. |