Comparative Pharmacokinetics and Food-Effect Bioavailability of a Sprinkle Formulation of Lubiprostone After Oral Administration in Healthy Volunteers

NCT03010631 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	Sucampo Pharma Americas, LLC
Phase	Phase 3
Status	COMPLETED
Enrolment	49
Start date	2016-11-16
Completion	2017-05

Conditions

• Healthy Volunteers

Interventions

• Cohort 1: Lubiprostone Capsule, Fasted
• Cohort 1: Lubiprostone Sprinkle Formulation, Fasted
• Cohort 2: Lubiprostone Sprinkle Formulation, Fed
• Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Primary outcomes

• Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite — 1 day
• Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite — 1 day

Countries

United States