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Mesalamine 4 gm/60 mL Rectal Enema

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Rowasa® 4 gm/60 mL Rectal Enema (Drug); Mesalamine 4 gm/60 mL Rectal Enema (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Shirley Ann Kennedy, M.D., Principal Investigator, Affiliation: Novum Pharmaceutical Research Services

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.

Clinical Details

Official title: A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 mL Rectal Enema Formulations

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax - Maximum Observed Concentration

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

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

Secondary outcome:

Cmax - Maximum Observed Concentration

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

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

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Novum Pharmaceutical Research Services, Pittsburgh, Pennsylvania 15206, United States
Additional Information

Starting date: May 2003
Last updated: September 1, 2009

Page last updated: August 23, 2015

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