At a glance
ClinicalIndex Comparison Record- ✓Age 18–55 years
- ✓Normal 12-lead ECG
- ✓Good health with normal vital signs and laboratory values
- ✕Active or recent alcoholism or drug addiction within 1 year
- ✕Smoker or recent smoking within 6 months
- ✕Routine consumption of foods/beverages that alter drug metabolism (grapefruit juice, coffee, tea, cola, chocolate, cocoa, caffeine, methyl-xanthines) or inability to refrain
- ✕Blood donation within 3 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparative Pharmacokinetics and Food-Effect Bioavailability of a Sprinkle Formulation of Lubiprostone After Oral Administration in Healthy Volunteers
In Brief
A Phase 3 clinical trial evaluating Cohort 1: Lubiprostone Capsule, Fasted, Cohort 1: Lubiprostone Sprinkle Formulation, Fasted, and 2 other interventions for Healthy Volunteers. Completed, enrolled 49 participants across 1 site.
Detailed Summary
A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
Study Details
Timeline
Interventions
Lubiprostone soft gelatin capsule administered under fasted conditions
Lubiprostone sprinkle formulation administered under fasted conditions
Lubiprostone sprinkle formulation administered under fed conditions
Lubiprostone sprinkle formulation administered under fasted conditions