Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

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