Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: The test olaparib tablet (T); Drug: The reference olaparib tablet (R)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • The First Affiliated Hospital of Bengbu Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Had BMI 18.0 kg/m^2, and weight ≥ 50 kg for male, or ≥ 45 kg for female
• Patients who were on olaparib treatment, had epithelial ovarian, fallopian tube, or primary peritoneal cancer, or were eligible for olaparib treatment judged investigators
• Had ECOG performance status 0-1
• Had life expectancy >12 weeks
• Had Adequate organ function or clinically irrelevant abnormal result
• Agreed to use adequate contraception from 14 days before treatment initiation to 6 months after last dose

Exclusion Criteria:

• Allergic to any component of study drugs
• Had central nervous system metastases (stable and asymptomatic metastases were acceptable)
• Had other malignancy within 5 years
• Had disease affecting swallow or absorption
• Received major surgery within 1 month before study drug administration
• Had major disease
• Had continuous grade 3-4 adverse event
• Had drug abuse
• Had (suspected) pneumonitis
• Participated in other clinical trial of drug or device within 1 month
• Lost or donated blood > 200 mL or received blood transfusion within 1 month
• With average alcohol consumption > 14 units/week or cigarette consumption > 20/day within 1 month
• Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
• Received strong or moderate CYP3A inducer or inhibitor within 3 half-lives of the drug
• Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine
• For female, pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Test-reference; Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days.	Drug: The test olaparib tablet (T); The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours; Drug: The reference olaparib tablet (R); The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours
Other: Reference-test; Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days.	Drug: The test olaparib tablet (T); The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours; Drug: The reference olaparib tablet (R); The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,ss	The maximum plasma drug concentration at steady state	Day 7
AUC0-τ	The area under the concentration-time curve between two dosings at steady state	0-12 hours

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): September 8, 2021
• Study Completion (Actual): September 8, 2021

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Olaparib
• Other Study ID Numbers: QL-YK3-052-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No