NCT05814809已完成1 期
Phase I Study to Evaluate the Safety and Pharmacokinetics of JP-1366 in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUCt of Zastaprazan(JP-1366 20mg)
研究概览
简要总结
To evaluate the safety and the pharmacokinetics of the JP-1366 20 mg tablet and capsule oral administration in healthy adult 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
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects ≥ 19 years of age
- •Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
排除标准
- •Subjects with clinically significant diseases or a medical history related to the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infections diseases, kidney and urinary system, psychiatric and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin, and ophthalmological system
- •Subjects who have a history of gastrointestinal surgery (except simple appendectomy or herniotomy) or have gastrointestinal disorders that may affect the absorption of the drug
- •Subjects who received inducers or inhibitors of drug metabolizing enzymes
- •Subjects who have hypersensitivity to this drug, ingredients of this drug, or benzimidazoles, or have a medical history thereof
- •Patients receiving drugs containing atazanavir, nelfinavir, or rilpivirine
- •Subjects who are judged ineligible to participate in this study by the principal investigator
研究组 & 干预措施
Sequence A
Experimental
R → Washout period(7days) → T
干预措施: JP-1366 20mg tablet (Drug)
Sequence A
Experimental
R → Washout period(7days) → T
干预措施: JP-1366 20mg capsule (Drug)
Sequence B
Experimental
T → Washout period(7days) → R
干预措施: JP-1366 20mg tablet (Drug)
Sequence B
Experimental
T → Washout period(7days) → R
干预措施: JP-1366 20mg capsule (Drug)
结局指标
主要结局
AUCt of Zastaprazan(JP-1366 20mg)
时间窗: Pre-dose(0 hour) and up to 34 hours in each period
Cmax of Zastaprazan(JP-1366 20mg)
时间窗: Pre-dose(0 hour) and up to 34 hours in each period
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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