NCT01882296Unknown1 期
A Block-randomized, Open-Label, Multiple Oral Dosing, Phase I Study to Explore Comparability of the Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects
Ahn-Gook Pharmaceuticals Co.,Ltd0 个研究点目标入组 40 人开始时间: 2013年6月20日最近更新:
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
- 40
- 主要终点
- 24h pH
研究概览
简要总结
Primary object: Evaluate Pharmacodynamic property and safety administered S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in healthy male subjects
Secondary object : Evaluate Dose-response of S-pantoprazole and pantoprazole and compare each dose-response
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 ~ 26 kg/m2
- •Blood Pressure : "140 mmHg ≥ sitting SBP ≥ 90 mmHg, 95 mmHg ≥ sitting DBP ≥ 50 mmHg"
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 and H.pylori positive
- •Hypersensitivity reactions to drugs of 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
AGSPT_10
Experimental
tablet, 10mg, QD, 7days
干预措施: AGSPT_10 (Drug)
AGSPT_20
Experimental
tablet, 20mg, QD, 7days
干预措施: AGSPT_20 (Drug)
AGSPT_40
Experimental
tablet, 20mg x 2, QD, 7days
干预措施: AGSPT_40 (Drug)
Pantoprazole_20
Active Comparator
tablet, 20mg, QD, 7days
干预措施: Pantoprazole_20 (Drug)
Pantoprazole_40
Active Comparator
tablet, 40mg, QD, 7days
干预措施: Pantoprazole_40 (Drug)
结局指标
主要结局
24h pH
时间窗: 24 hours
次要结局
- %Time pH>6(24 hours)
- % inhibition time gastric pH≤4(24 hours)
研究者
相似试验
Unknown
1 期
Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male SubjectsHealthy Male SubjectsNCT01821521Ahn-Gook Pharmaceuticals Co.,Ltd44
已完成
1 期
Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608HealthyNCT01703858Boehringer Ingelheim15
已完成
不适用
Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fasting StudyHealthyNCT01654705Ranbaxy Laboratories Limited80
已完成
不适用
Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fed StudyHealthyNCT01654718Ranbaxy Laboratories Limited40
已完成
1 期
Bioequivalence Study of Torrent Pharmaceutical Limited's Pantoprazole Sodium 40 mg Delayed Release Tablets Under Fasting ConditionsHealthyNCT01418417Torrent Pharmaceuticals Limited