None listed
Conditions
Interventions
Intervention1: EazyGlideâ?¢ (advanced tablet coating) coated placebo tablet: Dose-1 tablet in each part ( In swallowability part patient will intake orally and in palatability he will hold for 10 seco
Sponsors
Abbott Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult volunteer between 18 and 75 years of age at the time of enrolment who the Investigator believes that he/she can and will comply with the requirements of the protocol (e.g. study assessment completion). 2.Female of childbearing potential must have a negative pregnancy test and be non-lactating. 3.Subject with no systemic or local conditions or on any medications that might compromise the taste or smell 4.Subject who has never smoked, or who has smoked less than 100 cigarettes in his/her lifetime 5.Subject signs and dates the written informed consent 6.Agree to comply with the study procedures and requirements
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant or a nursing mother 2. Subject with any impairment in taste. 3. Subjects who are determined as being the risk group for COVID-19 as per applicable national guidelines. 4. Subject who do not agree to comply with the study procedures 5. Subject who is allergic to EazyGlideTM or conventional (Opadry) coatings or to the constituents of placebo tablets
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study objective is to assess and compare the ease of swallowability and palatability of EazyGlideâ?¢ coated, conventional (Opadry) coated, and uncoated placebo tablets1 in the adult population on 100 mm visual analogue scale (VAS)Timepoint: Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Objectives The safety objective is to evaluate the safety of EazyGlideTM coated, conventional (Opadry) coated, and uncoated placebo tablets.Timepoint: Day 1;To arrange the tablets, in the descending frequency, as per subjects overall order of preferenceTimepoint: Day 1;To assess the association between: a.Ease of swallowing versus amount of water taken to swallow, time to swallow, and tablet arrest3 while swallowing EazyGlideTM coated, conventional (Opadry) coated, and uncoated placebo tablets b.Tablet arrest versus amount of water taken to swallow and time to swallow EazyGlideTM coated, conventional (Opadry) coated, and uncoated placebo tabletsTimepoint: Day 1;To conduct the benefit-cost assessment using a modified contingent valuation technique by assessing the percentage of subjects who are willing to pay2 more for their most preferred tablet and to determine how much extra they are willing to pay for their most preferred tablet in comparison to their mid- and least preferred tabletsTimepoint: Day 1;To evaluate and compare the impact of gender (male and female) and age (â?¤ 54 years and â?¥ 55 years) on ease of swallowing, amount of water taken to swallow, time to swallow, tablet arrest, and overall palatability of EazyGlideTM coated, conventional (Opadry) coated, and uncoated placebo tabletsTimepoint: Day 1;To evaluate the proportion of subjects who have a change in psychological perception (in terms of difficulty in swallowing the tablet) before (by visual perception) and after swallowing each tablet (EazyGlideTM coated, conventional [Opadry] coated, and uncoated placebo tablets)Timepoint: Day 1;To identify if any correlation exists between subject socioeconomic class and willingness to pay for their most preferred tabletTimepoint: Day 1 | — |
Countries
India
Contacts
Public ContactDrShivani Acharya
Abbott Healthcare Private Limited
Outcome results
None listed