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The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Indomethacin 75mg ER Capsules |
|
| 2 | Active Comparator | Indocin 75mg SR Capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin 75mg Extended-Release Capsules, Sandoz | Drug |
| ||
| Indocin 75mg SR Capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence according to US FDA guidelines. | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony R Godfrey, Pharm. D. | PRACS Institute, LTD. | Principal Investigator |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
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