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NCT03010631 · ClinicalTrials.gov registry record · Phase 3
Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers
A Phase 3 study, sponsored by Sucampo Pharma Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
NCT03010631: Completed Phase 3 study, sponsored by Sucampo Pharma Americas.
NCT03010631 is a Phase 3 study that has completed, run by Sucampo Pharma Americas. The registered enrollment target is 49 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03010631, a Phase 3 study, has completed, sponsored by Sucampo Pharma Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
Study Summary
A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
Interventions
- DRUG Cohort 1: Lubiprostone Capsule, Fasted
- DRUG Cohort 1: Lubiprostone Sprinkle Formulation, Fasted
- DRUG Cohort 2: Lubiprostone Sprinkle Formulation, Fed
- DRUG Cohort 2: Lubiprostone Sprinkle Formulation, Fasted
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2016-11-16 |
| Est. Completion | 2017-05 |
| Phase | Phase 3 |
What the finished NCT03010631 record still lists
NCT03010631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Cohort 1: Lubiprostone Capsule, Fasted is the first listed.
NCT03010631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03010631 about?
NCT03010631 is a clinical study titled "Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers". A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
What is the current status of trial NCT03010631?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2016-11-16. Estimated completion is 2017-05.
What interventions are being tested in trial NCT03010631?
The interventions under investigation include: Cohort 1: Lubiprostone Capsule, Fasted (DRUG), Cohort 1: Lubiprostone Sprinkle Formulation, Fasted (DRUG), Cohort 2: Lubiprostone Sprinkle Formulation, Fed (DRUG), Cohort 2: Lubiprostone Sprinkle Formulation, Fasted (DRUG).
Who is sponsoring clinical trial NCT03010631?
This trial is sponsored by Sucampo Pharma Americas, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03010631's enrollment target sits among peer trials
49 1860th of 2000 higher than 139 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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