drugset / Trial / NCT01372423
Evaluation of Clinical Equivalence Between Two Lubiprostone Products
Phase 3
Completed
808 enrolled
Anchen Pharmaceuticals, Inc
Novum Pharmaceutical Research Services · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of lubiprostone 24 mcg capsules compared to the marketed formulation AMITIZA® (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed chronic idiopathic constipation.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-06
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lubiprostone | Small molecule | 24 ug | — |