Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers
Not Applicable
Completed
- Conditions
- Neoplasms
- Interventions
- Drug: The test olaparib tablet (T)Drug: The reference olaparib tablet (R)
- Registration Number
- NCT05860530
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Reference-test The test olaparib tablet (T) Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days. Reference-test The reference olaparib tablet (R) Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days. Test-reference The reference olaparib tablet (R) Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days. Test-reference The test olaparib tablet (T) Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China