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Multi centre Multiple Dose Study Comparing Olaparib Tablets 150 mg in Adult Patients with carcinoma of the ovary breast prostate or adenocarcinoma of the pancreas under Fasting Conditions

An Open Label Balanced Randomized Multi centre Multiple Dose Two Treatment Two Sequence Two Period Crossover Fully Replicate Steady State Oral Bioequivalence Study Comparing Olaparib Tablets 150 mg 150 mg x 2 Twice daily Manufactured by BDR Pharmaceuticals International Pvt Ltd India with Lynparza Olaparib Tablets 150 mg 150 mg x 2 Twice daily Marketing Authorization Holder Astrazeneca Ab Se 151 85 Sodertalje Sweden in Adult Patients with carcinoma of the ovary breast prostate or adenocarcinoma of the pancreas under Fasting Conditions - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113680
Enrollment
42
Registered
2026-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50-C50- Malignant neoplasms of breast Health Condition 2: C56- Malignant neoplasm of ovary Health Condition 3: C61- Malignant neoplasm of prostate Health Condition 4: C25- Malignant neoplasm of pancreas

Interventions

Intervention1: Olaparib Tablets 150 mg 150 mg x 2 Twice daily: Multiple oral dose of Olaparib Tablets 150 mg 150 mg x 2 Twice daily will be administered in each period Total Duration of the study is 1

Sponsors

BDR pharmaceuticals International Pvt Ltd
Lead Sponsor
Spinos Life Science and Research Private limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Male or non pregnant non lactating female between 18 65 years of age both inclusive Patient must meet one of the following disease indications Early Breast Cancer Patient 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 Germline BRCA mutation must be confirmed prior to initiation of olaparib OR Metastatic Breast Cancer Deleterious or suspected deleterious germline BRCA mutated gBRCAm HER2 negative metastatic breast cancer previously treated with chemotherapy in the neoadjuvant adjuvant or metastatic setting Patients with hormone receptor HR positive disease must have progressed on or be considered inappropriate for endocrine therapy Germline BRCA mutation must be confirmed prior to initiation of olaparib OR Advanced Ovarian Fallopian Tube Primary Peritoneal Cancer First line Maintenance Advanced BRCA mutated high grade epithelial ovarian fallopian tube or primary peritoneal cancer in complete or partial response to first line platinum based chemotherapy Note BRCA mutation germline or tumor must be confirmed prior to initiation

Exclusion criteria

Exclusion criteria: Patient with a known hypersensitivity to olaparib or any of the excipients of the product Patient receiving any systemic chemotherapy except abiraterone or prednisone or prednisolone or radiotherapy within 4 weeks prior to stabilization Patient who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to randomization Patient with any ongoing toxicities CTCAE Common Terminology Criteria for Adverse Events greater than or equal to grade 2 with the exception of alopecia caused by previous cancer therapy Patient who has administered any live vaccine within 28 days prior to randomization Patient with interstitial pneumonia or symptomatic diffuse fibrosis of the lungs Patient with known myelodysplastic syndrome acute myeloid leukemia Patient with known history risk of venous thromboembolic events Patient with symptomatic uncontrolled brain metastases Patient can receive stable doses of steroids before and during study as long as these were started at least 4 weeks prior to treatment

Design outcomes

Primary

MeasureTime frame
To evaluate the Bioequivalence of Olaparib Tablets 150 mg 150 mg x 2 Twice daily Manufactured by BDR Pharmaceuticals International Pvt Ltd India with Lynparza Olaparib Tablets 150 mg 150 mg x 2 Twice daily Marketing Authorization Holder Astrazeneca Ab Se 151 85 Sodertalje Sweden in Adult Patients with carcinoma of the ovary breast prostate or adenocarcinoma of the pancreas under Fasting ConditionsTimepoint: 64 Time points Day 04 00.00 Day 05 00.00 Day 06 00.00 00.50 01.00 01.50 02.00 02.25 02.50 02.75 03.00 04.00 06.00 07.00 08.00 10.00 12.00 Day 07 00.00 00.50 01.00 01.50 02.00 02.25 02.50 02.75 03.00 04.00 06.00 07.00 08.00 10.00 12.00 Day 11 00.00 Day 12 00.00 Day 13 00.00 00.50 01.00 01.50 02.00 02.25 02.50 02.75 03.00 04.00 06.00 07.00 08.00 10.00 12.00 Day 14 00.00 00.50 01.00 01.50 02.00 02.25 02.50 02.75 03.00 04.00 06.00 07.00 08.00 10.00 12.00—

Secondary

MeasureTime frame
To monitor the safety and tolerability of test product comparing with the reference product in Adult Patients with carcinoma of the ovary breast prostate or adenocarcinoma of the pancreas under Fasting ConditionsTimepoint: 64 Time points Day 04 00.00 Day 05 00.00 Day 06 00.00 00.50 01.00 01.50 02.00 02.25 02.50 02.75 03.00 04.00 06.00 07.00 08.00 10.00 12.00 Day 07 00.00 00.50 01.00 01.50 02.00 02.25 02.50 02.75 03.00 04.00 06.00 07.00 08.00 10.00 12.00 Day 11 00.00 Day 12 00.00 Day 13 00.00 00.50 01.00 01.50 02.00 02.25 02.50 02.75 03.00 04.00 06.00 07.00 08.00 10.00 12.00 Day 14 00.00 00.50 01.00 01.50 02.00 02.25 02.50 02.75 03.00 04.00 06.00 07.00 08.00 10.00 12.00—

Countries

India

Contacts

Public ContactDr Pradeep T

Spinos Life science and research private limited

pradeep.t@spinoslifescience.com08220586899

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026