An Open-Label, Randomized, Fasting, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-R713" and "R713R" in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cmax of Pranlukast
研究概览
简要总结
To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate in Healthy Adults.
详细描述
This study evaluates the pharmacokinetic characteristics and safety of pranlukast in healthy adults. It is a randomized, open-label, single-dose, two-period crossover trial conducted under fasting conditions. Pharmacokinetic samples are collected up to 24 hours after dosing, and standard safety assessments are performed throughout the study.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19 years or older at the time of screening.
- •Body mass index (BMI) between 18 and 30 kg/m².
- •Male subjects: body weight ≥ 50 kg.
- •Female subjects: body weight ≥ 45 kg.
- •Clinically healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory test results, as determined by the investigator.
- •Willing and able to provide written informed consent after receiving a full explanation of the study.
- •Subjects (and their partners, if applicable) agree to use highly effective, non-hormonal contraception from the first dosing day until one week after the last dose.
排除标准
- •Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.
- •Participation in any clinical trial involving investigational products within 6 months prior to the first dose.
- •Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.
- •History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
- •Known hypersensitivity to the investigational product or its components.
- •Known metabolic or genetic disorders such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or phenylketonuria.
- •History of clinically significant psychiatric illness.
- •Pregnant or breastfeeding women, or women with a possibility of pregnancy.
研究组 & 干预措施
Pranlukast Test Formulation
Two-period, single-dose, crossover study
干预措施: AJU-R713 (Drug)
Pranlukast Test Formulation
Two-period, single-dose, crossover study
干预措施: R713R (Drug)
Pranlukast Reference Formulation
Two-period, single-dose, crossover study (reversed order)
干预措施: AJU-R713 (Drug)
Pranlukast Reference Formulation
Two-period, single-dose, crossover study (reversed order)
干预措施: R713R (Drug)
结局指标
主要结局
Cmax of Pranlukast
时间窗: 0 hour ~ 24 hour after drug administration
To assess the maximum observed plasma concentration (Cmax) of Pranlukast
AUCt of Pranlukast
时间窗: 0 hour ~ 24 hour after drug administration
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Pranlukast
次要结局
未报告次要终点