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Sponsored by: |
Salix Pharmaceuticals |
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Information provided by: | Salix Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00622375 |
The current study is being conducted to evaluate the relative bioavailability and single- and multiple-dose pharmacokinetics of encapsulated mesalamine granules(eMG) in healthy subjects.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: mesalamine |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase I, Single- And Multiple-Dose, Relative Bioavailability and Pharmacokinetic Study of Encapsulated Mesalamine Granules Administered Orally to Healthy Volunteers |
Enrollment: | 24 |
Study Start Date: | February 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: mesalamine
encapsulated mesalamine granules
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Salix Pharmaceuticals |
Study ID Numbers: | MPPK1003 |
Study First Received: | February 14, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00622375 |
Health Authority: | United States: Food and Drug Administration |
Pharmacokinetic study Healthy subjects |
Mesalamine Healthy |
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