Status:
COMPLETED
Mesalamine 4 gm/60 mL Rectal Enema
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00840203
Start Date
May 1 2003
End Date
June 1 2003
Last Update
August 19 2024
Active Locations (1)
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1
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, United States, 15206