Taste Assessment Study of SHP429 in Healthy Adult Subjects

Shire

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Mesalamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02125292

SHP429-102

Details and patient eligibility

About

The purpose of this study is to compare the palatability of SHP429 capsule contents delivered via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into a cup and administered with water).

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• normal, healthy, adult male and female volunteers, without evidence of active or chronic disease

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Mesalamine (Vanilla Yogurt)

Experimental group

Description:

One 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt

Treatment:

Drug: Mesalamine

Mesalamine (Applesauce)

Experimental group

Description:

One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce

Treatment:

Drug: Mesalamine

Mesalamine (Dosing Cup)

Experimental group

Description:

One 500mg capsule contents emptied into a dosing cup and taken with water

Treatment:

Drug: Mesalamine