NCT02071381已完成1 期
A Randomized, Open Label, Single-Dose, 6-sequence, 3-period, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between DW330SR and DW1030 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Trans-OH as Main Metabolites of DW330SR, DW330SR, Cmax, AUClast of DW1030
研究概览
简要总结
The purpose of this study is to evaluate drugs interactions to compare pharmacokinetics in groups of monotherapy DW330SR, monotherapy DW1030, and coadministration DW330SR and DW1030
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy Adult males aged 20~40 years at screening visit
- •Subjects with range of 19 kg/m2 ~ 27 kg/m2 as BMI measurements at screening visit
- •Subjects with BP range of below:
- •90 mmHg ≤ Systolic BP ≤ 140 mmHg 50 mmHg ≤ Diastolic BP ≤ 90mmHg
- •Subjects who voluntarily agreed with written consent that be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the reguirement of the study
排除标准
- •Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.)
- •Subjects with history of gastrointestinal disease (ex, Chrones dz, peptic ulcer, etc) affect the absorption of Investigational drugs or history of surgery (except for a simple appendectomy or hernia surgery)
- •Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID and antibiotics) including ingredient of DW330SR and DW1030 and Food
研究组 & 干预措施
A
Experimental
only DW330SR 45mg
干预措施: DW330SR 45mg (Drug)
B
Experimental
only DW1030 75mg
干预措施: DW1030 75mg (Drug)
C
Experimental
DW330SR 45mg and DW1030 75mg
干预措施: DW330SR 45mg (Drug)
C
Experimental
DW330SR 45mg and DW1030 75mg
干预措施: DW1030 75mg (Drug)
结局指标
主要结局
Trans-OH as Main Metabolites of DW330SR, DW330SR, Cmax, AUClast of DW1030
时间窗: -28 ~ -2day(screening), -1day, 1day, 2day
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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