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Taste Assessment Study of SHP429 in Healthy Adult Subjects

NCT ID: NCT02125292

Last Updated: 2021-06-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-02

Study Completion Date

2014-06-19

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mesalamine (Vanilla Yogurt)

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

Group Type EXPERIMENTAL

Mesalamine

Intervention Type DRUG

Mesalamine (Applesauce)

One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce

Group Type EXPERIMENTAL

Mesalamine

Intervention Type DRUG

Mesalamine (Dosing Cup)

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

Group Type EXPERIMENTAL

Mesalamine

Intervention Type DRUG

Interventions

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Mesalamine

Intervention Type DRUG

Other Intervention Names

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Pentasa, SHP429

Eligibility Criteria

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Inclusion Criteria

* normal, healthy, adult male and female volunteers, without evidence of active or chronic disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Clinical Pharmacology of Miami, Inc.

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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SHP429-102

Identifier Type: -

Identifier Source: org_study_id

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