Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

Study Overview
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Brief Summary
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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.

Official Title
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Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: The test olaparib tablet (T)
* Drug: The reference olaparib tablet (R)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test-reference<br>Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days. | Drug: The test olaparib tablet (T)<br>* The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours<br>Drug: The reference olaparib tablet (R)<br>* The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours<br>|
| Other: Reference-test<br>Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days. | Drug: The test olaparib tablet (T)<br>* The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours<br>Drug: The reference olaparib tablet (R)<br>* The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss | The maximum plasma drug concentration at steady state | Day 7 | 
| AUC0-τ | The area under the concentration-time curve between two dosings at steady state | 0-12 hours |