Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Takeda
• Treatments: Dexlansoprazole; Lansoprazole

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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