NCT01821521Unknown1 期
A Randomized, Open Label, Single-dose, 2x2 Crossover Study to Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects
Ahn-Gook Pharmaceuticals Co.,Ltd1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Primary object : Evaluate pharmacokinetic property administered S-pantoprazole 20mg and Pantoprazole 40mg in healthy male subjects
Secondary object : Evaluate safety administered S-pantoprazole 20mg and Pantoprazole 40mg in healthy male subjects
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult healthy males 20 to 45 years at screening.
- •BMI : 19kg/m2 ~ 26kg/m2
- •Blood Pressure : "140 > sitting SBP ≥ 90mmHg, 90 > sitting DBP ≥ 60mmHg"
排除标准
- •Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
- •Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer)or surgery(except for Appendectomy, Hernia repair) affected the absorption of medications
- •Have history of GERD, Gastric ulcer, Duodenal ulcer
- •Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of benzimidazole(ex:pantoprazole, NSAID, antibiotic)
- •Have a history of drug abuse
- •Unusual diet affected the absorption, distribution, metabolism, excretion of medications
- •Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
- •Subject who takes inhibitors and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30days
- •Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
- •Subject who have taken habitually caffeine (caffeine > 5 units/day)
- •Subject who have drunken habitually (alcohol > 21 units/week, 1 unit = pure alcohol 10ml)or who are unable to quit drinking during this study or smoker
- •Subjects deemed ineligible by investigator based on other reasons
研究组 & 干预措施
Pantoloc 40mg
Active Comparator
tablet, q.d.
干预措施: Pantoloc 40mg (Drug)
AGSPT_L20
Experimental
tablet, q.d.
干预措施: AGSPT_L20 (Drug)
结局指标
主要结局
Cmax
时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
AUClast
时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
次要结局
- AUCinf(0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours)
- Tmax(0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours)
- T1/2β(0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours)
研究者
研究点 (1)
Loading locations...
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