Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets
Condition: Gastroesophageal Reflux Disease; Erosive Esophagitis; Heartburn
MeSH terms: Gastroesophageal Reflux; Esophagitis; Heartburn
Intervention: Dexlansoprazole
Intervention description: Dexlansoprazole delayed-release orally disintegrating tablets
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 25 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

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

Eligibility 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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