NCT07162441招募中1 期
A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Study to Evaluate the Pharmacokinetic Interaction and the Safety of UIC202502 and UIC202505 in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- AUCτ
研究概览
简要总结
This study is open-label, multiple-dose, two-intervention group, single-sequence, crossover design to compare the safety and pharmacokinetics of UIC202502 and UIC202505 when administered alone or in combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Subjects aged 19 years or older at the time of screening.
- •Subjects with a body weight greater than 50 kg (≥45 kg for females) and a body mass index (BMI) between 18.0 and 30.0 kg/m² at screening.
- •(BMI (kg/m²) = weight (kg) / height (m)²)
- •Subjects with no clinically significant congenital or chronic diseases, pathological symptoms or findings at screening.
- •Subjects determined by the principal investigator to be suitable for diagnostic procedures and electrocardiogram assessments
- •Subjects who agree to use an effective method of contraception (excluding hormonal agents) recognized as appropriate in clinical trials from the first administration of the investigational drug until 14 days after the last administration, together with their spouse or partner.
- •Subjects who have provided written informed consent after receiving a full explanation and demonstrating an understanding of the purpose, procedures, and characteristics of this clinical trial and the investigational drug.
排除标准
- •Subjects with clinically significant diseases or a history of conditions involving the digestive, cardiovascular, endocrine, respiratory, hematologic/oncologic infectious, renal/genitourinary, psychiatric/neurologic, musculoskeletal, immune, otorhinolaryngologic, dermatologic, or ophthalmologic systems.
- •Subjects with a history of gastrointestinal surgery (excluding simple appendectomy or hernia repair) or gastrointestinal disease that may affect drug absorption.
- •Subjects who have taken drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 1 month before the first dose, or drugs that may interfere with this clinical trial within 10 days before the first dose
- •Subjects who have participated in another clinical trial or bioequivalence study and received an investigational drug within 6 months before the first administration.
- •Subjects who have donated whole blood or blood components within 2 weeks, or received a blood transfusion within 4 weeks before the first administration.
- •Subjects who meet any of the following criteria within 1 month before the first dose:
- •Average alcohol consumption exceeding 21 drinks/week for men
- •Average alcohol consumption exceeding 14 drinks/week for women
- •(1 drink = 50 mL soju, 30 mL liquor, or 250 mL beer)
- •Smoking more than 20 cigarettes/day on average
- •Subjects judged by the principal investigator to be unsuitable for participation in this clinical trial for any reason other than the above selection or exclusion criteria.
- •Female subjects who are pregnant, suspected of being pregnant, or lactating
研究组 & 干预措施
Arm A
Experimental
干预措施: treatment A (Drug)
Arm A
Experimental
干预措施: treatment C (Drug)
Arm B
Experimental
干预措施: treatment B (Drug)
Arm B
Experimental
干预措施: treatment C (Drug)
结局指标
主要结局
AUCτ
时间窗: 0 to 24hr
Evaluation PK
Cmax,ss
时间窗: 0 to 24hr
Evaluation PK
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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