Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets
Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease; Erosive Esophagitis; Heartburn
Intervention: Dexlansoprazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Takeda Official(s) and/or principal investigator(s): Medical Director Clinical Science, Study Director, Affiliation: Takeda
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 Details
Official title: An Open-Label Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Subjects : TAK-390MR(OD)_107
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets
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.
Eligibility
Minimum age: 25 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. The male or female sensory panelist is between 25 and 80 years of age (inclusive),
healthy volunteers for study participation, and is able to read, understand, and sign
and date a written informed consent form (ICF) and any required privacy authorization
before study participation.
2. In the opinion of the investigator, the participant is capable of understanding and
complying with protocol requirements.
3. The sensory panelist is qualified based on documented training and experience: All
panelists will be provided by Senopsys, LLC: Panelists have been trained to detect,
identify, recognize, and accurately describe different taste elements and flavor
combinations and to measure oral disintegration times. Training is initially
accomplished by tasting model compounds and learning to recognize and describe these
accurately. These abilities are then honed and refined through additional experience
in performing product testing.
Exclusion Criteria:
1. Has a history of any illness that, in the opinion of the investigator or the sensory
panelist's general practitioner, might confound the results of the study or pose an
additional risk in administering study drug(s) to the sensory panelist. This may
include but is not limited to: a history of relevant drug or food allergies; history
of cardiovascular or central nervous system disease; history or presence of
clinically significant pathology; recent history of disease involving head, neck,
esophagus (especially malignancy, radiation therapy, fungal infection where taste
perception can be altered) or history of mental disease.
2. If female, the sensory panelist is pregnant, nursing, planning to become pregnant
during the study.
3. Has a known hypersensitivity to dexlansoprazole or any component of dexlansoprazole
delayed-release orally disintegrating (OD) tablet or proton pump inhibitor (PPI)
(including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole).
4. Is currently taking any contraindicated medications.
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Locations and Contacts
Woburn, Massachusetts 01801, United States
Additional Information
Starting date: February 2014
Last updated: February 22, 2015
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