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

PHASE3CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

November 16, 2016

Primary Completion Date

December 23, 2016

Study Completion Date

May 31, 2017

Conditions
Healthy Volunteers
Interventions
DRUG

Cohort 1: Lubiprostone Capsule, Fasted

Lubiprostone soft gelatin capsule administered under fasted conditions

DRUG

Cohort 1: Lubiprostone Sprinkle Formulation, Fasted

Lubiprostone sprinkle formulation administered under fasted conditions

DRUG

Cohort 2: Lubiprostone Sprinkle Formulation, Fed

Lubiprostone sprinkle formulation administered under fed conditions

DRUG

Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Lubiprostone sprinkle formulation administered under fasted conditions

Trial Locations (1)

78209

ICON, San Antonio

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Sucampo Pharma Americas, LLC

INDUSTRY