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

Constipation is a common gastrointestinal problem estimated to effect 2-27 % of the population in United States . It is found more commonly in women and elderly . The prevelance of constipation and growing demand for treatment dictate the need for safe and effective treatment options . Lubiprostone is the first chloride channel activator approved by FDA for long term treatment of chronic idiopathic constipation in adult men and women . To provide a generic medicine to the U.S population Dr Reddy's Laboratories intends to conduct this study to evaluate that the Lubiprostone manufactured by it is equally effective and safe as marketed AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.)