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The purpose of this study is to evaluate the pharmacokinetics and safety of oral administration of BR9001 compared with BR900A in healthy subjects
This is an open-label, randomized, crossover study to evaluate the pharmacokinetics and safety. Within each period, randomized subjects will be take 2 dosing regimens that BR9001 or BR900A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | BR900A - Wash out - BR9001 |
|
| Sequence 2 | Experimental | BR9001 - Wash out - BR900A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR9001 | Drug | BR9001 is a test drug as generic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration of drug in plasma of BR9001 and BR900A | 0-24 hours after administration |
| AUClast | Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of BR9001 and BR900A | 0-24 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Ran Yoon, M.D. PhD | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | 700-721 | South Korea |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| BR900A |
| Drug |
BR900A is a reference drug |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |