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CTRI Number  CTRI/2025/11/097849 [Registered on: 21/11/2025] Trial Registered Prospectively
Last Modified On: 21/04/2026
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to compare how Olaparib 150 mg tablets made by SP Accure Labs and Lynparza 150 mg tablets by AstraZeneca act in the body in women with BRCA-mutated advanced breast cancer under fasting conditions. 
Scientific Title of Study   An Open label, balanced, randomized, multi-center, two-treatment, two-period, two-sequence, multiple dose, steady state, crossover, oral bioequivalence study of Olaparib 150 mg Tablets by SP Accure Labs Private Limited with Lynparza 150 mg Tablet (Olaparib) of AstraZeneca Pharmaceuticals LP., in female patients with deleterious or suspected deleterious germline BRCA-mutated advanced metastatic breast cancer under fasting condition. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/094/1224; Ver 00; 16 Apr 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lakshmaiah KC 
Designation  Principal Investigator 
Affiliation  Srinivasam Cancer Care Multi-Speciality Hospital 
Address  Srinivasam Cancer Care Multi-Speciality Hospital, 36, 1st A Main, 5th Cross (Nethravathi Street), Maruthi Nagar, Nagarbhavi main road, Bnagalore

Bangalore
KARNATAKA
560072
India 
Phone  7019607648  
Fax    
Email  srinivasamcancercarecrc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lakshmaiah KC 
Designation  Principal Investigator 
Affiliation  Srinivasam Cancer Care Multi-Speciality Hospital 
Address  Srinivasam Cancer Care Multi-Speciality Hospital, 36, 1st A Main, 5th Cross (Nethravathi Street), Maruthi Nagar, Nagarbhavi main road, Bnagalore

Bangalore
KARNATAKA
560072
India 
Phone  7019607648  
Fax    
Email  srinivasamcancercarecrc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Lakshmaiah KC 
Designation  Principal Investigator 
Affiliation  Srinivasam Cancer Care Multi-Speciality Hospital 
Address  Srinivasam Cancer Care Multi-Speciality Hospital, 36, 1st A Main, 5th Cross (Nethravathi Street), Maruthi Nagar, Nagarbhavi main road, Bnagalore

Bangalore
KARNATAKA
560072
India 
Phone  7019607648  
Fax    
Email  srinivasamcancercarecrc@gmail.com  
 
Source of Monetary or Material Support  
Intercontinental Pharma. 6021 142nd Avenue North, Clearwater, Florida, 33760 USA 
 
Primary Sponsor  
Name  Intercontinental Pharma 
Address  6021 142nd Avenue North, Clearwater, Florida, 33760 USA. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
ICBio Clinical Research Pvt Ltd  NO. 16 ICBio Tower, Chikkabettahalli, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura, Bangalore-560097 Karnataka  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arun Seshachalam  GVN Riverside Hospital  Thimmarayasamuthiram, Trichy-ChennaiNational Highway (NH-45) Thiruvanaikoil,Tiruchirappalli Tamil Nadu – 620005
Tiruchirappalli
TAMIL NADU 		 9786220191

arunonco@gmail.com 
Dr Nitin Laxman chaudhari  Jeevan Jyoti Cancer Hospital  13, Vivekanand Nagar, Jilha Peth, Near Swatantra Chowk, Behind Hotel Rupali, Jalgaon, Maharashtra Jalgaon Maharashtra – 425001
Jalgaon
MAHARASHTRA 		 8380007270

nlchaudhari@yahoo.co.in 
Dr Lakshmaiah KC  Srinivasam Cancer Care Multi Speciality Hospital,  No. 36, 1st A, 5th Cross, (Netravathi Street), Maruthi Nagar, Nagarbhavi Main Road, Bengaluru (Bangalore) Urban Karnataka – 560072
Bangalore
KARNATAKA 		 7019607648

srinivasamcancercarecrc@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
Aram Hospital Institutional Ethics Committee  Approved 
Shri Amrithum Hospital  Approved 
Yashodhan Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lynparza® 150 mg Tablet (Olaparib) of AstraZeneca Pharmaceuticals LP  After an overnight fast of at least 10.00 hours before scheduled time for dosing, single dose of Reference product (R): Lynparza® 150 mg Tablet (Olaparib) (2x150mg) total 300 mg will be administered orally in sitting posture with approximately 240±5 mL of drinking water depending on the randomization schedule. In period-I (Day 1 to Day 8), patients will receive Reference product for 8 days based on the randomization schedule. In period-II (Day 9 to Day 16), patients will be switched to the other product for a second period of 8 days. 
Intervention  Olaparib 150mg Tablet by SP Accure  After an overnight fast of at least 10.00 hours before scheduled time for dosing, single dose of Test product (T): Olaparib 150 mg Tablets (2x150mg) total 300 mg will be administered orally in sitting posture with approximately 240±5 mL of drinking water depending on the randomization schedule. In period-I (Day 1 to Day 8), patients will receive Test product for 8 days based on the randomization schedule. In period-II (Day 9 to Day 16), patients will be switched to the other product for a second period of 8 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1) Patients on treatment with advanced metastatic breast cancer.
2) Patients that are already receiving a stable dose of olaparib tablets (2 x 150 mg tablets) 300 mg twice daily for at least 10 days.
3) Patients requiring Olaparib in the dose of 300 mg (2 x 150 mg tablets) twice daily as per the discretion of the Investigators, these patients will be stabilized on Olaparib as a part of study and those patients that tolerate Olaparib in the dose of 300 mg twice daily for 10 days will be randomized in the study.
4) Maintenance treatment of adult patients with advanced metastatic Breast cancer (adenocarcinoma) who are in complete or partial response to first line chemotherapy.
5) Patients have an estimated survival of at least 3 months.
6) Adult female subject of 18-60 years (both inclusive) of age.
7) Non-smoking, non-pregnant, non-lactating female patient with a body mass index in the range of 18. 50 – 30.00 kg/m2 (both inclusive).
8) Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
9) Willing to be available for the entire study period and to comply with protocol requirements.
10) Subjects with adequate laboratory values as determined at the time of eligibility assessment.
11) Patients with ECOG performance status of 0-2 (Attachment 01).
12) Patients with absence of blood transfusion in the 28 days prior to randomization.
13) Women of non-childbearing potential with documented evidence of hysterectomy/ bilateral salpingectomy/ bilateral oophorectomy at least 6 months prior to IMP administration) or postmenopausal for at least 12 consecutive months.
Or
14) Women of child bearing potential must have negative Urine pregnancy test at screening visit and negative serum beta-hcG test during check-in and must agree to use an effective method of avoiding pregnancy (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 [at least 6 months prior to drug administration] sexual partner) for at least 4 weeks prior to drug administration, during the study and up to 6 months after the last dose of drug administration. Cessation of birth control after this point should be discussed with a responsible physician.
15) With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
16) Able to read and understand the Informed Consent Document as a whole and communicate effectively if required. 
 
ExclusionCriteria 
Details  1) History of known hypersensitivity to Olaparib or its components which in the opinion of the Investigator would compromise the safety of the patient or the results of the study.

2) Patients found positive for HIV 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) History of other malignancies in the last five years.

5) Patients with Pneumonitis.

6) Patients with severe hepatic impairment Child Pugh classification category C.

7) Patients who received any chemotherapy radiotherapy or any other anticancer therapy within four weeks from the last dose prior to first dosing in Period 01 or a longer period depending on the defined characteristics of the agents used.

8) History or presence of any active infection or uncontrolled systemic disease for example cardiovascular disease hypertension diabetes mellitus etc or any clinically significant disease condition disorder or abnormal laboratory finding that in the opinion of the Investigator may either put the patient at risk because of participation in the study or influence the study results or the patient ability to participate in the study.

9) Patients had major surgery within four weeks prior to first dosing in Period 01 or who have not recovered from prior major surgery.

10) In the opinion of the Investigator the patient will not be compliant with the requirements of the study procedures.

11) Receipt of an investigational medicinal product or participation in another drug research study involving drug administration within thirty days prior to first dosing in Period 01 for the current study.

12) Usage of strong and moderate CYP3A4 inhibitors for example cimetidine ciprofloxacin grapefruit juice or strong and moderate CYP3A4 inducers for example carbamazepine phenytoin St Johns Wort rifampicin within thirty days prior to first dosing in Period 01 refer Attachment 02 for a full list of prohibited medications.

13) History of difficulty in accessibility of veins or intolerance to direct venipuncture.

14) Pregnant or lactating females.

15) Patient with positive test result on Breath alcohol analyzer test at the time of baseline or randomization visit.

16) Positive on urine test for drugs of abuse including amphetamines barbiturates benzodiazepines marijuana cocaine and morphine prior to receiving the first dose of investigational medicinal product in the study.

17) History or presence of alcoholism or drug abuse.

18) Patients with psychiatric illness or social situations that would limit compliance with study requirements.

19) Difficulty in swallowing tablets.

20) Patients having problems with fasting restriction.

21) History or presence of clinically significant lactose galactose or fructose intolerance.

22) Participated in any clinical investigation requiring repeated blood sampling blood donation or have blood loss of more than five hundred millilitres in past ninety days prior to dosing.

23) Participated in any clinical study within the past ninety days prior to first dosing.

24) Consumption of alcohol or alcoholic products within twenty four hours prior to dosing in each study period and throughout sampling time points.

25) Positive alcohol breath or urine screen for drug of abuse tests during check in in each study period.

26) Consumption of xanthine or its derivative containing food or beverages for example chocolates tea coffee or cola drinks within forty eight hours prior to dosing in each study period and throughout sampling time points.

27) Consumption of grapefruit or its juice within seventy two hours prior to dosing in each study period and throughout sampling time points.

28) Incapable of understanding the informed consent information.

29) Evidence of an uncooperative attitude. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the rate and extent of absorption of Olaparib 150 mg Tablets by SP Accure Labs Private Limited with Lynparza 150 mg Tablet (Olaparib) of AstraZeneca Pharmaceuticals LP., in female patients with advanced metastatic Breast cancer (adenocarcinoma) under fasting conditions.  The venous blood samples will be withdrawn at pre-dose 0.00 hours on Day 1, 6, 7, 8, 14, 15 & 16 and 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 6.00, 9.00 and 12.00 hours post-dose following drug administration on Day 6, 7, 8, 14, 15 and 16.  
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of the study subjects after administration of Olaparib 150 mg Tablets in female patients with advanced metastatic Breast cancer (adenocarcinoma) under fasting conditions.  At vital signs (blood pressure, pulse rate, respiratory rate and axillary/body temperature) measurement Before morning dose of Day 1, Day 6 to Day 9, and Day 14 to Day 16 (within 2.00 hrs before dosing), at 3.00 hours after morning dose on Day 6 to Day 9 and Day 14 to Day 16, End of the study Day 16 and Follow up on Day 24±2.

The well-being of subjects will be ascertained at each vital sign measurement. 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   15/12/2025 
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="0"
Days="24" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Descriptive statistics of primary and secondary pharmacokinetic parameters will be computed and reported for Olaparib. 

ANOVA, 90% confidence interval using schuirmann’s two one-sided tests for bioequivalence, power and ratio analysis, for ln-transformed pharmacokinetic parameters CmaxSS and AUC0-tau will be computed and reported for Olaparib.

Based on the statistical results of 90% confidence interval for the ratio of the geometric least squares means for ln-transformed pharmacokinetic parameters CmaxSS and AUC0-tau will be computed and reported for Olaparib, conclusion will be drawn for Test Product-T vs. Reference Product-R.

Bioequivalence of the test product with that of the reference product will be concluded if 90% confidence interval falls within the acceptance range of 80.00-125.00% for ln-transformed pharmacokinetic parameters CmaxSS and AUC0-tau will be computed and reported for Olaparib.

 
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