Mesalamine 4 gm/60 mL Rectal Enema

NCT ID: NCT00840203

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2003-06-30

Brief Summary

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

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mesalamine

Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period

Group Type: EXPERIMENTAL

Mesalamine 4 gm/60 mL Rectal Enema

Intervention Type: DRUG

1 x 4 gm/60 mL, single-dose

Rowasa®

Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period

Group Type: ACTIVE_COMPARATOR

Rowasa® 4 gm/60 mL Rectal Enema

Intervention Type: DRUG

1 x 4 gm/60 mL, single-dose

Interventions

Rowasa® 4 gm/60 mL Rectal Enema

1 x 4 gm/60 mL, single-dose

Intervention Type: DRUG

Mesalamine 4 gm/60 mL Rectal Enema

1 x 4 gm/60 mL, single-dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males and females, 18 years or older, with a body mass index (BMI) of 30 or less.
• Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
• Signed informed consent form, which meets all criteria of current FDA regulations.
• If female and of child bearing potential prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g. condom, IUD, hormonal contraceptives).

Exclusion Criteria

• If female pregnant, lactating, or likely to become pregnant during the study.
• History of allergy or sensitivity to mesalamine or other salicylic drugs (e.g. aspirin, sulfasalazine) or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
• Colitis, hemorrhoids, anal fissures, or other disease of the anus, rectum or colon.
• Significant history or current evidence of chronic infections disease, system disorder or organ disorder.
• History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
• Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives).
• Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
• Receipt of any drug as part of a research study within 30 days prior to dosing.
• Drug or alcohol addiction requiring treatment in the past 12 months.
• Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing.
• Positive test for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
• Positive test results for drugs of abuse at screening.
• Positive serum pregnancy test at screening.
• Unable or unwilling to tolerate multiple venipunctures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Shirley Ann Kennedy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceutical Research Services

Locations

Novum Pharmaceutical Research Services

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

10336014

Identifier Type: -

Identifier Source: org_study_id