Overview

Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation

Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to evaluate the clinical equivalence and safety of the test formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation
Phase:
Phase 3
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Collaborator:
Parexel
Treatments:
Lubiprostone