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Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets

Gastroesophageal Reflux Disease Clinical Trial

Official title:
An Open-Label Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Subjects : TAK-390MR(OD)_107

Clinical Trial Summary

The purpose of this study is to measure the in-vivo disintegration time of a single dexlansoprazole delayed-release orally disintegrating (OD) tablet.

Clinical Trial Description

The drug being tested in this study is called dexlansoprazole. An orally disintegrating (OD) form of dexlansoprazole is being tested to look at the average time that it takes for one tablet to disintegrate in the mouth of healthy volunteers. At the point at which the panelist would normally swallow the granules, they will record the time and expectorate the disintegrated tablet mass and not actually swallow the tablet or granules.

The study will enroll approximately 8 healthy volunteers. All participants will take one dexlansoprazole 30 mg OD tablet on up to three separate study days. No more than 60 mg of dexlansoprazole will be tested in any one day.

This single-centre trial will be conducted in the United States. The overall time to participate in this study is approximately 2 weeks. Participants will make up to 4 visits to the clinic, and will be contacted by telephone approximately 1 week after last dose of study drug for a follow-up assessment. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02096458
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 1
Start date February 2014
Completion date February 2014
View Details
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