A Randomized, Open-Label, Single-Dose, Two-Period Crossover Study in Healthy Adults to Assess Bioequivalence Between Test and Reference Formulations of Vadadustat 150 mg Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)
研究概览
简要总结
This study is to assess the bioequivalence of a test formulation of vadadustat (A) compared to a reference formulation of vadadustat (B)
详细描述
This is a randomized, open-label, single-dose, two-period crossover study in healthy adults to assess the bioequivalence of a test formulation of vadadustat compared to the reference formulation of vadadustat. Blood samples for vadadustat PK will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 55 years of age, inclusive, at time of informed consent.
- •Healthy subjects per Investigator judgment as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations.
- •Minimum weight of 45 kg with Body mass index (BMI) between 18 and 29.5 kg/m2, inclusive.
- •Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure
- •Willing and able to comply with the requirements of the study protocol.
排除标准
- •Current or past history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, history of cancer (except non-melanoma skin cancer) or history of chemotherapy use.
- •Any surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to gastric bypass surgery or gastric or duodenal ulcers.
- •History of severe allergic or anaphylactic reactions.
- •Chronic daily medication use.
- •History of drug abuse
- •Excessive alcohol consumption
- •Smoking and the use of nicotine-containing products
- •Consumption of grapefruit or grapefruit juice, pomelo, star fruit, Seville or Moro (blood) orange, or their associated products
- •Participation in another clinical trial or exposure to any investigational agent.
- •Donation of blood or significant blood loss or plasma donation.
- •Any condition that would interfere with the ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.
研究组 & 干预措施
Regimen A
vadadustat reference tablets
干预措施: vadadustat reference tablets (Drug)
Regimen B
vadadustat test tablets
干预措施: vadadustat test tablets (Drug)
结局指标
主要结局
Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)
时间窗: Baseline visit, 48 hours
Area under plasma concentration-time curve from 0 to last sampling point (AUCall)
时间窗: Baseline visit, 48 hours
Area under plasma concentration-time curve from 0 to infinity (AUCinf)
时间窗: Baseline visit, 48 hours
Observed maximum concentration (Cmax)
时间窗: Baseline visit, 48 hours
次要结局
- Time to reach Cmax(Baseline visit, 48 hours)
- Terminal half-life (t1/2)(Baseline visit, 48 hours)
- Time to reach Tmax(Baseline visit, 48 hours)
- Mean residence time (MRT)(Baseline visit, 48 hours)
- Apparent total body clearance (CL/F)(Baseline visit, 48 hours)
- Elimination rate constant (Kel)(Baseline visit, 48 hours)
- Apparent volume of distribution (Vd/F)(Baseline visit, 48 hours)