Comparative Pharmacokinetics and Food-Effect Bioavailability of a Sprinkle Formulation of Lubiprostone After Oral Administration in Healthy Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite
研究概览
简要总结
A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
详细描述
To compare the pharmacokinetics of the sprinkle formulation of lubiprostone, as compared to lubiprostone capsules and to determine the effect of food on the bioavailability and plasma pharmacokinetics of lubiprostone sprinkle.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is male or female, between 18 and 55 years of age, inclusive.
- •Has a 12-lead electrocardiogram (ECG) within normal limits and is in good health based upon review of medical history, physical examination results, vital signs (within normal range), and normal laboratory profile for both blood and urine.
排除标准
- •Has an active or recent history of alcoholism or drug addiction (within 1 year prior)
- •Is a smoker or has a recent history of smoking (within 6 months)
- •Routinely consumes food known to alter drug metabolism (i.e., grapefruit juice, coffee, tea, cola, chocolate, cocoa, or other caffeine or methyl-xanthine containing foods or beverages) and/or cannot refrain from these items
- •Has donated blood within 3 months
- •Has a medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
研究组 & 干预措施
Cohort 1 (Treatment Sequence AB)
Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted
干预措施: Cohort 1: Lubiprostone Capsule, Fasted (Drug)
Cohort 1 (Treatment Sequence AB)
Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted
干预措施: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted (Drug)
Cohort 1 (Treatment Sequence BA)
Cohort 1: Treatment B. Sprinkle Formulation, Fasted (7-day Washout) then Treatment A. Capsule Fasted
干预措施: Cohort 1: Lubiprostone Capsule, Fasted (Drug)
Cohort 1 (Treatment Sequence BA)
Cohort 1: Treatment B. Sprinkle Formulation, Fasted (7-day Washout) then Treatment A. Capsule Fasted
干预措施: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted (Drug)
Cohort 2 (Treatment Sequence CD)
Cohort 2: Treatment C: Sprinkle Formulation, Fed (7-day Washout) then Treatment D: Sprinkle Formulation, Fasted
干预措施: Cohort 2: Lubiprostone Sprinkle Formulation, Fed (Drug)
Cohort 2 (Treatment Sequence CD)
Cohort 2: Treatment C: Sprinkle Formulation, Fed (7-day Washout) then Treatment D: Sprinkle Formulation, Fasted
干预措施: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted (Drug)
Cohort 2 (Treatment Sequence DC)
Cohort 2: Treatment D: Sprinkle Formulation, Fasted (7-day Washout) then Treatment C. Sprinkle Formulation, Fed
干预措施: Cohort 2: Lubiprostone Sprinkle Formulation, Fed (Drug)
Cohort 2 (Treatment Sequence DC)
Cohort 2: Treatment D: Sprinkle Formulation, Fasted (7-day Washout) then Treatment C. Sprinkle Formulation, Fed
干预措施: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted (Drug)
结局指标
主要结局
Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite
时间窗: 1 day
Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite
时间窗: 1 day
次要结局
- Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions(1 day)
- Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition(1 day)