Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02125292 | Taste Assessment Study of SHP429 in Healthy Adult Subjects | PHASE1 | COMPLETED | 18 | — | — | Jun 2, 2014 | Jun 19, 2014 | Jun 3, 2021 | 1 | United States |
A taste assessment was completed immediately after investigational product was administered to assess the subject's taste/liking of the formulation. The assessment consisted of a 5-point rating scale. Participants were asked to choose one of the following responses to the statement "The taste was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.
An aftertaste assessment was completed 5 minutes after administration of investigational product to assess whether the participants detected an aftertaste. The participants answered "Yes" or "No" to the following question: "Was there an aftertaste?" The number of participants who answered "Yes" is reported.
An aftertaste assessment was completed 5 minutes after administration of investigational product to assess the subject's rating of aftertaste and means of administration. The assessment consisted of a 5-point rating scale. The participants were asked to choose one of the following responses to the statement "The aftertaste (if present) was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.
The participants were asked to answer "Yes" or "No" to the following question: "Would you be willing to take medicine this way on a regular basis if necessary?" The number of participants who answered "Yes" is reported.
| Arm | Type | Description |
|---|---|---|
| Mesalamine (Vanilla Yogurt) | EXPERIMENTAL | One 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt |
| Mesalamine (Applesauce) | EXPERIMENTAL | One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce |
| Mesalamine (Dosing Cup) | EXPERIMENTAL | One 500mg capsule contents emptied into a dosing cup and taken with water |
| Name | Type | Description |
|---|---|---|
| Mesalamine | DRUG | - |
Inclusion Criteria: * normal, healthy, adult male and female volunteers, without evidence of active or chronic disease