Mesalamine 4 gm/60 mL Rectal Enema

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00840203
First received: February 6, 2009
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Rowasa® 4 gm/60 mL Rectal Enema
Drug: Mesalamine 4 gm/60 mL Rectal Enema
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 mL Rectal Enema Formulations

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: May 2003
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesalamine
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
1 x 4 gm/60 mL, single-dose
Active Comparator: Rowasa®
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
1 x 4 gm/60 mL, single-dose

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840203

Locations
United States, Pennsylvania
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Shirley Ann Kennedy, M.D. Novum Pharmaceutical Research Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00840203     History of Changes
Other Study ID Numbers: 10336014
Study First Received: February 6, 2009
Results First Received: June 30, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014