Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers

Phase 3 Completed 49 enrolled Sucampo Pharma Americas, LLC Takeda · collab

RandomizedCrossoverOpen-labelTreatment

Summary

A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.

Timeline

Start: 2016-11-16
Primary completion: 2016-12-23
Completion: 2017-05

Publications

Adams A, Barish C, Chen A, Dennis P, Krause R, Lichtlen P, Losch-Beridon T, Mareya S, Schneider J. Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation. Adv Ther. 2021 Jun;38(6):2936-2952. doi: 10.1007/s12325-021-01707-9. Epub 2021 Apr 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lubiprostone	Small molecule	48 ug	Oral

Indications

No indication recorded.