Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

• Status: Completed
• Trial end date: 2021-09-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.
• Treatments: Olaparib

Criteria

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

• 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