Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo

Mean SBM Consistency Score Within 1 Week

Stool consistency associated with SBMs was rated according to the 7-point Bristol Stool Form Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass), 2 = Sausage-shaped but lumpy, 3 = Like a sausage but with cracks on the surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges (passed easily), 6 = Fluffy pieces with ragged edges, a mushy stool, 7 = Watery, no solid pieces; entirely liquid. Scores in the mid-range of this scale indicate better stool consistency.

Time frame: during the 1-week treatment period

Mean SBM Straining Score Within 1 Week

Bowel straining associated with SBMs was rated on a scale of 0-4 where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Higher score indicates more straining, so a worse condition.

Time frame: during the 1-week treatment period

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is an episode which occur after the administration of the first dose of study medication and within 7 days after final dose.

Time frame: From first dose of study medication to follow-up (up to 15 days)