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

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.

Inclusion Criteria:

- Subject is male or female, between 18 and 55 years of age, inclusive.

- Subject 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:

- Subject has an active or recent history of alcoholism or drug addiction (within 1 year
prior)

- Subject is a smoker or has a recent history of smoking (within 6 months)

- Subject 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

- Subject has donated blood within 3 months

- Subject has a medical/surgical condition that might interfere with the absorption,
distribution, metabolism, or excretion of the study medication.