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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesalamine | Drug | encapsulated mesalamine granules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Audrey Shaw, PhD | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |