An Open-Label, Randomized, Crossover Study to Assess the Comparative Bioavailability of New TEV-56286 Formulations Compared to a Reference TEV-56286 Capsule Formulation Following Single-Dose Administration in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Maximum Observed Drug Concentration (Cmax)
研究概览
简要总结
The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants.
The secondary objective is to evaluate the safety and tolerability of TEV-56286.
The planned duration for each participant is approximately 70 days which includes a 45 day screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18.5 kg/m2 to 32.0 kg/m2 (inclusive)
- •Females of childbearing potential agree to take appropriate measures to prevent pregnancy during the study
- •Males who do not have a documented vasectomy or are not congenitally sterile must agree to abstinence or use of barrier method with spermicide with female partner. Male participant who is having sexual intercourse with a woman of childbearing potential who is not currently pregnant will be advised of her requirement to use an additional highly effective contraceptive method
- •NOTE - Additional criteria apply, please contact the investigator for more information
排除标准
- •Participation in another clinical trial simultaneously
- •Females who are lactating, breastfeeding, or intends to become pregnant over the course of the study
- •History of alcohol, drug or any other substance, abuse, addiction or dependence in the last 12 months (except for caffeine)
- •Major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of IMP, or surgery scheduled during the study or follow-up period
- •Donated blood or blood products (eg, white blood cells [WBCs], platelets, etc.) within the 60 days before screening, or has donated blood or blood products at least twice within the 6 months before screening, or has donated plasma within 7 days of the screening visit or has received blood or blood products in the 6 weeks before screening
- •Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope, or previous personal treatment for high blood pressure
- •NOTE - Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
Cohort 1
Random sequence of test and reference formulations
干预措施: TEV-56286 Test (Drug)
Cohort 1
Random sequence of test and reference formulations
干预措施: TEV-56286 Reference (Drug)
Cohort 2
Random sequence of test and reference formulations
干预措施: TEV-56286 Test (Drug)
Cohort 2
Random sequence of test and reference formulations
干预措施: TEV-56286 Reference (Drug)
结局指标
主要结局
Maximum Observed Drug Concentration (Cmax)
时间窗: Up to Day 17
Area Under the Drug Concentration-Time Curve from Time 0 to Last Measurable Drug Concentration [AUC(0-t)]
时间窗: Up to Day 17
Area Under the Drug Concentration-Time Curve from Time 0 to Infinity [AUC(0-inf)]
时间窗: Up to Day 17
次要结局
- Number of participants with at least one treatment-emergent adverse event(Up to Day 26)
- Number of participants who did not complete the trial due to an adverse event(Up to Day 26)