PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

Sponsor

Bausch Health Americas, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00622375

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The current study is being conducted to evaluate the relative bioavailability and single- and multiple-dose pharmacokinetics of encapsulated mesalamine granules(eMG) in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: mesalamine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase I, Single- And Multiple-Dose, Relative Bioavailability and Pharmacokinetic Study of Encapsulated Mesalamine Granules Administered Orally to Healthy Volunteers

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: mesalamine encapsulated mesalamine granules

Arm

Intervention/Treatment

Experimental: 1

Drug: mesalamine

encapsulated mesalamine granules

Outcome Measures

Primary Outcome Measures

Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The subject is Male, or female of Non-childbearing potentia.l
The subject is female of childbearing potential, who has a negative serum pregnancy test at screen and agrees to using appropriate birth control.
The subject is between the ages of 18 and 45 years.
The subject has a body mass index (BMI) between 18 and 32 kg/m2 (weight/[height]).

Exclusion Criteria:

The subject is seropositive for human immunodeficiency virus (HIV),hepatitis B surface antigen, and/or hepatitis C virus.
The subject has any clinically significant medical, social, or emotional problem.
The subject is pregnant or lactating
The subject has a history of clinically significant renal, hepatic,endocrine, oncological,gastrointestinal, or cardiovascular disease or a history of epilepsy, asthma, diabetes mellitus, psychosis, glaucoma, or severe head injury.
The subject is currently receiving mesalamine or aspirin containing products
The subject has a history of viral, bacterial, or fungal infection within 4 weeks of screening.
The subject has an acute illness within 1 week of study-drug administration.
The subject has an abnormal nutritional status, including unconventional, alternative,and abnormal diets; excessive or unusual vitamin intake; malabsorption; psychological eating disorders; difficulty swallowing medication; significant recent weight change; etc.
The subject has clinically significant allergies.
The subject has a hypersensitivity or allergy to mesalamine or other salicylate.
The subject has known or suspected alcohol abuse or illicit drug use within the past year
The subject has used tobacco (or nicotine products) during the 6 months prior to screening
The subject has participated in an investigational drug study within the 30 days before receiving study drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Dallas	Texas	United States	75247

Sponsors and Collaborators

Bausch Health Americas, Inc.

Investigators

Study Director: Audrey Shaw, PhD, Bausch Health Americas, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bausch Health Americas, Inc.

ClinicalTrials.gov Identifier:

NCT00622375

Other Study ID Numbers:

MPPK1003

First Posted:

Feb 25, 2008

Last Update Posted:

Nov 18, 2019

Last Verified:

Nov 1, 2019

Keywords provided by Bausch Health Americas, Inc.

Pharmacokinetic study

Healthy subjects

Additional relevant MeSH terms:

Mesalamine

Study Results

No Results Posted as of Nov 18, 2019