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Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations

NCT ID: NCT00802451

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2003-03-31

Brief Summary

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The purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subjects.

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Drug

Group Type ACTIVE_COMPARATOR

Mesalamine

Intervention Type DRUG

Reference Drug

Group Type ACTIVE_COMPARATOR

Mesalamine

Intervention Type DRUG

Interventions

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Mesalamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy men or women, 18 to 55 years of age
* weight within +/- 25% for height and weight for body frame
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria

* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to mesalamine
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 28 days prior to study dosing
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Padagis LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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10216928

Identifier Type: -

Identifier Source: org_study_id