NCT07486895已完成1 期
An Open-label, Randomized, Crossover Trial in Healthy Subjects to Assess Dose Strength Equivalence Among 164.4 and 328.8 mg Strengths of Oral Centanafadine QD XR Capsules
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年3月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of Centanafadine
研究概览
简要总结
The purpose of this study is to demonstrate dose strength equivalence of 2 × 164.4 milligrams (mg) centanafadine (CTN) once daily (QD) extended-release (XR) capsules to a 1 × 328.8 mg centanafadine QD XR capsule 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
- 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
- •Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m^2) (inclusive).
- •In good health as determined by:
- •Medical history
- •Physical examination
- •Electrocardiogram (ECG)
- •Serum/urine chemistry, hematology, and serology tests.
- •Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
排除标准
- •Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigators or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
- •History of drug and/or alcohol abuse within 2 years prior to screening.
- •History of or current hepatitis or acquired immunodeficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies.
- •History of any significant drug allergy or known or suspected hypersensitivity.
- •Participants having taken an investigational drug within 30 days prior to screening.
- •Previous exposure to centanafadine.
- •Any history of significant bleeding or hemorrhagic tendencies.
- •A history of difficulty in donating blood.
- •The donation of blood or plasma within 30 days prior to the first dose of investigational medical product (IMP).
- •Use of prescription, over-the-counter, herbal medication or vitamin supplements within 14 days prior to the first dose of IMP and antibiotics within 30 days prior to the first dose of IMP.
- •Any participant who, in the opinion of the investigator, should not participate in the trial. Note: Other protocol-specified inclusion/exclusion criteria may apply.
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Centanafadine
时间窗: Up to Day 5
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine
时间窗: Up to Day 5
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine
时间窗: Up to Day 5
次要结局
- Percentage (%) of Extrapolated AUC of Centanafadine(Up to Day 5)
- Time to Reach Maximum Plasma Concentration (Tmax) of Centanafadine(Up to Day 5)
- Terminal Phase Elimination Half-life (t1/2,z) of Centanafadine(Up to Day 5)
- Apparent Clearance from Plasma (CL/F) After Extravascular Administration of Centanafadine(Up to Day 5)
研究者
研究点 (1)
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