Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets
|ClinicalTrials.gov Identifier: NCT02096458|
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : March 6, 2015
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease Erosive Esophagitis Heartburn||Drug: Dexlansoprazole||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Subjects : TAK-390MR(OD)_107|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Dexlansoprazole 30 mg
Dexlansoprazole 30 mg delayed-release orally disintegrating tablets at Assessment 1 Day 1, Assessment 2 Day 1, and Assessment 3 Day 1.
Dexlansoprazole delayed-release orally disintegrating tablets
- Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets [ Time Frame: Day 1 ]The disintegration time is the total time from when the participant places the tablet on their tongue until the time at which the participant would normally swallow the remaining materials from the disintegrated tablet. The average disintegration time will be calculated for each participant based on 3 separate tests.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096458
|United States, Massachusetts|
|Woburn, Massachusetts, United States, 01801|
|Study Director:||Medical Director Clinical Science||Takeda|