NCT07715305尚未招募1 期
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of AD-116A Compared to AD-1161 in Healthy Adult Male Volunteers Under Fasting Conditions
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve during dosing interval (AUCt)
研究概览
简要总结
The study compare and evaluate the bioequivalence between the administration of AD-116A and the administration of AD-1161 in healthy adult male volunteers
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- •The Age equal to or greater than 19 in healthy adult male volunteers at the time of screening visit
排除标准
- •Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- •Other exclusions applied
结局指标
主要结局
Area under the plasma concentration-time curve during dosing interval (AUCt)
时间窗: pre-dose (0hour) to 72hours
AUCt of AD-116A
Maximum concentration of drug in plasma (Cmax)
时间窗: pre-dose (0hour) to 72hours
Cmax of AD-116A
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male SubjectsBenign Prostatic HyperplasiaNCT07444385Addpharma Inc.44
尚未招募
1 期
A Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232Diabetes MellitusNCT07538466Addpharma Inc.50
尚未招募
1 期
A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 in Healthy Adult SubjectsChronic Heart FailureNCT07476157Addpharma Inc.70
尚未招募
1 期
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of AD-230 in Healthy AdultsChronic Liver Disease (CLD)NCT07521241Addpharma Inc.52
尚未招募
不适用
An Open Label Single Dose Two Period Oral Bioequivalence Study Comparing Zifi O Tablets Cefixime 200 mg and Ofloxacin 200 mg Tablets in Healthy Adult Human Subjects Under Fasting ConditionsCTRI/2026/01/100801FDC Limited46