Comparative Pharmacokinetics and Food-Effect Bioavailability of a Sprinkle Formulation of Lubiprostone After Oral Administration in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sucampo Pharma Americas, LLC
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite
Study Overview
Brief Summary
A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Cohort 1 (Treatment Sequence AB)
Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted (Drug)
Outcomes
Primary Outcomes
Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite
Time Frame: 1 day
Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite
Time Frame: 1 day
Secondary Outcomes
- 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)