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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 is a Phase 3 study that has completed, run by Sucampo Pharma Americas. The registered enrollment target is 49 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03010631
The ClinicalTrials.gov registry entry for NCT03010631 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sucampo Pharma Americas, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cohort 1: Lubiprostone Capsule, Fasted is the first listed.
NCT03010631 reports 0 study locations.
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.
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