Conditions: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 49
Healthy volunteers: yes

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

Detailed description:
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.

Arms:
arm 1: Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted arm 2: Cohort 1: Treatment B. Sprinkle Formulation, Fasted (7-day Washout) then Treatment A. Capsule Fasted arm 3: Cohort 2: Treatment C: Sprinkle Formulation, Fed (7-day Washout) then Treatment D: Sprinkle Formulation, Fasted arm 4: Cohort 2: Treatment D: Sprinkle Formulation, Fasted (7-day Washout) then Treatment C. Sprinkle Formulation, Fed

Interventions: intervention 1: Cohort 1: Lubiprostone Capsule, Fasted intervention 2: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted intervention 3: Cohort 2: Lubiprostone Sprinkle Formulation, Fed intervention 4: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted
Intervention descriptions: intervention 1: Lubiprostone soft gelatin capsule administered under fasted conditions intervention 2: Lubiprostone sprinkle formulation administered under fasted conditions intervention 3: Lubiprostone sprinkle formulation administered under fed conditions intervention 4: Lubiprostone sprinkle formulation administered under fasted conditions

Protocol document: