drugset / Trial / NCT01993875
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Phase 3
Completed
164 enrolled
Mallinckrodt
Sucampo AG · collabSucampo Pharma Americas, LLC · collabTakeda · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.
Timeline
- Start
- 2013-10
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lubiprostone | Small molecule | 12 ug | Oral |