An Open-label, Randomized, Fasting, Single-Crossover Study to Compare the Pharmacokinetic Interactions and Safety of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration [Cmax]
研究概览
简要总结
An open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetic interactions and safety after co-administration of YHR2402 and YHR2403 compared to the administration of YHR2402 independently in healthy subjects
详细描述
26 healthy subjects will be randomized to one of the 2 groups in the same ratio.
"YHR2402" and "YHR2402"+"YHR2403" will be administered to Subjects in group 1 by crossover design on day 1, 15
"YHR2402"+"YHR2403" and "YHR2402" will be administered to Subjects in group 2 by crossover design on day 1, 15.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who are 19 years old and under 55 years old at the screening visit
- •Those whose weight is over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
- •Those who express their voluntary consent to participate in the trial by signing a written consent
- •Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test
排除标准
- •Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration
- •Others who are judged ineligible to participate in the trial by the principal investigator
研究组 & 干预措施
Sequence Group 1
13 subjects, Cross-over, Single dose of YHR2402 on day 1, Co-Administration of YHR2402 and YHR2403 on day 15
干预措施: YHR2402 (Drug)
Sequence Group 1
13 subjects, Cross-over, Single dose of YHR2402 on day 1, Co-Administration of YHR2402 and YHR2403 on day 15
干预措施: YHR2402+YHR2403 (Drug)
Sequence Group 2
13 subjects, Cross-over, Co-Administration of YHR2402 and YHR2403 on day 1, Single dose of YHR2402 on day 15
干预措施: YHR2402 (Drug)
Sequence Group 2
13 subjects, Cross-over, Co-Administration of YHR2402 and YHR2403 on day 1, Single dose of YHR2402 on day 15
干预措施: YHR2402+YHR2403 (Drug)
结局指标
主要结局
Maximum plasma concentration [Cmax]
时间窗: 0-96 hours
of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine
Area under the plasma drug concentration-time curve [AUCt]
时间窗: 0-96 hours
of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine
次要结局
- Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf](0-96 hours)
- Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf](0-96 hours)
- Time of Maximum observed plasma concentration [Tmax](0-96 hours)
- Apparent Terminal Elimination Half-life [t1/2](0-96 hours)