Neoplasms
Conditions
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.
Interventions
DRUGThe test olaparib tablet (T)
The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours
DRUGThe reference olaparib tablet (R)
The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,ss | Day 7 | The maximum plasma drug concentration at steady state |
| AUC0-τ | 0-12 hours | The area under the concentration-time curve between two dosings at steady state |
Countries
China
Outcome results
None listed