Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

Neoplasms Clinical Trial

Official title:

Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05860530
• Other study ID #: QL-YK3-052-001
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: September 8, 2021

Study information

• Verified date: May 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• The test olaparib tablet (T)
The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours
• The reference olaparib tablet (R)
The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax,ss	The maximum plasma drug concentration at steady state	Day 7
Primary	AUC0-t	The area under the concentration-time curve between two dosings at steady state	0-12 hours