A Phase 1, Randomized, Open-label, 2-way Cross-over Study to Evaluate the Bioequivalence Between a Single Oral Dose of Esomeprazole 40 mg Capsules and Esomeprazole 40 mg Tablets in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Esomeprazole
研究概览
简要总结
The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram (mg) tablets and capsules.
详细描述
The drug being tested in this study is called esomeprazole. Esomeprazole is being tested in healthy participants in order to evaluate the bioequivalence between a single oral dose of esomeprazole tablet and capsule. The study will enroll 52 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment sequences:
- Esomeprazole 40 mg capsule + Esomeprazole 40 mg tablet
- Esomeprazole 40 mg tablet + Esomeprazole 40 mg capsule
All participants will be asked to take one capsule or tablet on Day 1 of each Intervention Period based on the treatment sequence to which the participant has been assigned.
This single center trial will be conducted in the United States. The overall duration to participate in this study is 36 days. Participants will visit the clinic on Day -1 and remained confined until Day 1 of Intervention Period 1 and 2. A washout period of minimum 6 days will be maintained between the dose in each Intervention Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a healthy adult male or female participant.
- •Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
- •Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 30 kilogram per square meter (kg/m^2), inclusive at Screening and Day -1.
排除标准
- •Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the Takeda Medical Monitor may be warranted.
- •Has a history of significant gastro intestinal (GI) disorders manifested with persistent, chronic or intermittent nausea, vomiting, diarrhea, or has a current or recent (within 6 months) GI disease that would influence the absorption of drugs (example, a history of malabsorption, severe esophageal reflux, peptic ulcer disease or erosive esophagitis), or any gastrointestinal-related surgical intervention..
- •Has a known hypersensitivity to any component of the formulation of esomeprazole capsules or tablets or compounds with the same mechanism of action (dexlansoprazole, lansoprazole, omeprazole, rabeprazole, pantoprazole), or related compounds.
研究组 & 干预措施
Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet
Esomeprazole 40 mg, capsule, orally, once on Day 1 of Intervention Period 1, followed by 6 days of washout period, followed by esomeprazole 40 mg tablet, orally, once on Day 1 of Intervention Period 2.
干预措施: Esomeprazole Capsule (Drug)
Esomeprazole 40 mg Capsule + Esomeprazole 40 mg Tablet
Esomeprazole 40 mg, capsule, orally, once on Day 1 of Intervention Period 1, followed by 6 days of washout period, followed by esomeprazole 40 mg tablet, orally, once on Day 1 of Intervention Period 2.
干预措施: Esomeprazole Tablet (Drug)
Esomeprazole 40 mg Tablet + Esomeprazole 40 mg Capsule
Esomeprazole 40 mg, tablet, orally, once on Day 1 of Intervention Period 1, followed by 6 days of washout period, followed by esomeprazole 40 mg capsule, orally, once on Day 1 of Intervention Period 2.
干预措施: Esomeprazole Capsule (Drug)
Esomeprazole 40 mg Tablet + Esomeprazole 40 mg Capsule
Esomeprazole 40 mg, tablet, orally, once on Day 1 of Intervention Period 1, followed by 6 days of washout period, followed by esomeprazole 40 mg capsule, orally, once on Day 1 of Intervention Period 2.
干预措施: Esomeprazole Tablet (Drug)
结局指标
主要结局
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Esomeprazole
时间窗: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for Esomeprazole
时间窗: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Esomeprazole
时间窗: Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose
次要结局
未报告次要终点