Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cmax,ss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Test-reference
Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days.
干预措施: The test olaparib tablet (T) (Drug)
Test-reference
Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days.
干预措施: The reference olaparib tablet (R) (Drug)
Reference-test
Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days.
干预措施: The test olaparib tablet (T) (Drug)
Reference-test
Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days.
干预措施: The reference olaparib tablet (R) (Drug)
结局指标
主要结局
Cmax,ss
时间窗: Day 7
The maximum plasma drug concentration at steady state
AUC0-τ
时间窗: 0-12 hours
The area under the concentration-time curve between two dosings at steady state
次要结局
未报告次要终点