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

NCT03010631 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-03-09

Study results available
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Summary

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

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

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Sucampo Pharma Americas, LLC

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-16
Primary Completion
2016-12-23
Completion
2017-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03010631 on ClinicalTrials.gov