Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

NCT05860530 | Completed

• 1 other identifier: QL-YK3-052-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Test-reference

OTHER

Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days.

Drug: The test olaparib tablet (T); Drug: The reference olaparib tablet (R)

Reference-test

OTHER

Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days.

Drug: The test olaparib tablet (T); Drug: The reference olaparib tablet (R)

Interventions

The test olaparib tablet (T) DRUG

The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours

Reference-test; Test-reference

The reference olaparib tablet (R) DRUG

The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours

Reference-test; Test-reference

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 16, 2023
• Study Start: May 10, 2021
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

CN (1)