Conditions: Gastroesophageal Reflux Disease Erosive Esophagitis Heartburn
Keywords: Drug therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Dexlansoprazole 30 mg delayed-release orally disintegrating tablets at Assessment 1 Day 1, Assessment 2 Day 1, and Assessment 3 Day 1.

Interventions: intervention 1: Dexlansoprazole
Intervention descriptions: intervention 1: Dexlansoprazole delayed-release orally disintegrating tablets

Protocol document: