A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Lubiprostone soft gelatin capsule administered under fasted conditions
Lubiprostone sprinkle formulation administered under fasted conditions
Lubiprostone sprinkle formulation administered under fed conditions
ICON
San Antonio, Texas, United States
Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite
Time frame: 1 day
Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite
Time frame: 1 day
Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition
Time frame: 1 day
Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions
Time frame: 1 day
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Lubiprostone sprinkle formulation administered under fasted conditions