Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sucampo AG; Sucampo Pharma Americas, LLC
• Collaborators: Sucampo Pharma Americas, LLC; Takeda
• Treatments: Lubiprostone

Criteria

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.