A Single-dose, Open-label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18.0 and 32.0 kg/m^2, inclusive
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECGs, vital sign measurements, and clinical laboratory evaluations as assessed by the investigator or designee
- •Female participants must be of non-childbearing potential (surgically sterile or postmenopausal)
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee
- •Evidence of any infections (bacterial, viral, fungal, parasitic, COVID-19) within 4 weeks prior to the first dose of study drug, as determined by the investigator or designee
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator or designee
- •History or presence of an abnormal ECG prior to the first dose of the study drug that, in the opinion of the investigator or designee, is clinically significant
- •Abnormal liver function tests, as defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >upper limit of normal (ULN) range
- •Positive hepatitis panel and/or positive human immunodeficiency virus test
- •Note: Other protocol defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
Sequence 1
Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.
干预措施: Zanubrutinib (Drug)
Sequence 2
Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Predose and up to 48 hours postdose up to Day 10
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
时间窗: Predose and up to 48 hours postdose up to Day 10
Apparent volume of distribution (Vz/F)
时间窗: Predose and up to 48 hours postdose up to Day 10
Rate of decrease of concentration in the terminal phase (λz)
时间窗: Predose and up to 48 hours postdose up to Day 10
Time of the maximum observed plasma concentration (Tmax)
时间窗: Predose and up to 48 hours postdose up to Day 10
Apparent oral clearance (CL/F)
时间窗: Predose and up to 48 hours postdose up to Day 10
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
时间窗: Predose and up to 48 hours postdose up to Day 10
Apparent terminal elimination half-life (t1/2)
时间窗: Predose and up to 48 hours postdose up to Day 10
次要结局
- Number of participants with adverse events (AEs)(Up to 30 days after last dose; up to approximately 7 weeks)
- Number of participants with clinically significant laboratory values(Up to 30 days after last dose; up to approximately 7 weeks)
- Number of participants with clinically significant electrocardiogram (ECG) results(Up to 30 days after last dose; up to approximately 7 weeks)
- Number of participants with clinically significant vital sign measurements(Up to 30 days after last dose; up to approximately 7 weeks)