NCT02096458

Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Gastroesophageal Reflux Disease
• Erosive Esophagitis
• Heartburn

Interventions

Type	Name	Description
DRUG	Dexlansoprazole	Dexlansoprazole delayed-release orally disintegrating tablets

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2014-03-26
• Last updated: 2015-03-06
• Results posted: 2015-03-06

Locations

1 site across 1 country: United States