Trials / Completed
CompletedNCT03010631
Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers
Comparative Pharmacokinetics and Food-Effect Bioavailability of a Sprinkle Formulation of Lubiprostone After Oral Administration in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Sucampo Pharma Americas, LLC · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2016-11-16
- Primary completion
- 2016-12-23
- Completion
- 2017-05-01
- First posted
- 2017-01-05
- Last updated
- 2020-03-09
- Results posted
- 2020-03-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03010631. Inclusion in this directory is not an endorsement.