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

Completed · Phase 3

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT03010631

Run by

Sucampo Pharma Americas, LLC

People needed

49

Starts

2016-11-16

Expected to finish

2017-05-01

Last updated by the study team

2020-03-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ICON — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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