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Mesalamine 4 gm/60 mL Rectal Enema

NCT00840203 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-08-19

Study results available
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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

Interventions

DRUG

Rowasa® 4 gm/60 mL Rectal Enema

1 x 4 gm/60 mL, single-dose

DRUG

Mesalamine 4 gm/60 mL Rectal Enema

1 x 4 gm/60 mL, single-dose

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Shirley Ann Kennedy, M.D. · Novum Pharmaceutical Research Services

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2003-06-30
Completion
2003-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00840203 on ClinicalTrials.gov