Mesalamine 4 gm/60 mL Rectal Enema

NCT00840203 | Completed Phase 1 Results

• 1 other identifier: 10336014
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  Blood samples collected over 48 hour period

• AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

  Bioequivalence based on AUC0-inf

  Blood samples collected over 48 hour period

• AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

  Bioequivalence based on AUC0-t

  Blood samples collected over 48 hour period

Secondary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Blood samples collected over 48 hour period

• AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

  Blood samples collected over 48 hour period

• AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

  Blood samples collected over 48 hour period

Study Arms (2)

Mesalamine

EXPERIMENTAL

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

Drug: Mesalamine 4 gm/60 mL Rectal Enema

Rowasa®

ACTIVE COMPARATOR

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

Drug: Rowasa® 4 gm/60 mL Rectal Enema

Interventions

Rowasa® 4 gm/60 mL Rectal Enema DRUG

1 x 4 gm/60 mL, single-dose

Rowasa®

Mesalamine 4 gm/60 mL Rectal Enema DRUG

1 x 4 gm/60 mL, single-dose

Mesalamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Pittsburgh, Pennsylvania, 15206, United States

Location

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Shirley Ann Kennedy, M.D.

  Novum Pharmaceutical Research Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: May 1, 2003
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2003
• Last Updated: August 19, 2024
• Results First Posted: August 4, 2009

Record last verified: 2024-08

Locations

US (1)