Bioequivalence Study of Olaparib 150 mg F.C Tablet of Test (OLAPAREX®, Arena Hayat, Iran)

Bioequivalence Study of Olaparib 150 mg F.C Tablet of Test (OLAPAREX®, Arena Hayat, Iran) and Reference Drug (LYNPARZA® 150 mg F.C Tablet, Astrazeneca, UK)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240804062647N16

Enrollment

Registered

2026-04-18

Start date

2026-05-05

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Patients with advanced ovarian cancer with a definite or suspected BRCA mutation, HER2-negative metastatic breast cancer treated with chemotherapy in the neoadjuvant setting..

Interventions

Intervention 1: Intervention group: Olaparib 150 mg F.C tablet of the Test Drug (Arena Hayat, Iran) is admintered in the first period. Cross-over design without washout period is conducted. Right afte

Eligibility

Sex/Gender

Female

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Patients who take the test drug Olaparib twice a day (300 mg BID) for at least 3.5 days, followed by the same regimen for the reference drug. Non-vegetarian. Patients with advanced ovarian cancer with a definite or suspected BRCA mutation, HER2-negative metastatic breast cancer treated with chemotherapy in the neoadjuvant setting. Not too obese or thin.

Exclusion criteria

Exclusion criteria: Smoking. Alcohol and drug abuse. Allergy to Statins. Abnormal liver or kidney function. AIDS, HBV, HCV, syphilis. Abnormal WBC, hemoglobin, or platelets. History of acute or chronic GI, liver, kidney, or cardiovascular disease. Concomitant use of grapefruit or CYP3A4 inhibitors.

Design outcomes

Primary

Measure	Time frame
Drug concentration in blood. Timepoint: 0 , 0.5 , 1 , 2.5 , 3 , 3.5 , 4 , 4.5 , 5 , 5.5 , 6 , 7 , 8 , 10 , 12hours after drug administration. Method of measurement: Liquid Chromatography with Mass-Mass Detector.	—

Secondary

Measure	Time frame
Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded. This is done after completing the instrumental analysis of the samples using the WinNonLin software developed by Phoenix Company.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time plots.	—

Measure

Time frame

Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded. This is done after completing the instrumental analysis of the samples using the WinNonLin software developed by Phoenix Company.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time plots.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMassoud Amanlou

Tehran University of Medical Sciences

amanlou@tums.ac.ir+98 21 6695 9067

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026