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To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose |
|
| Sequence B | Experimental | Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Drug | Drug | AJU-G721 |
| |
| Reference Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Tamsulosin. | To assess the maximum observed plasma concentration (Cmax) of Tamsulosin. | 0 hour ~ 48 hour after drug administration |
| AUCt of Tamsulosin | To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Tamsulosin | 0 hour ~ 48 hour after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bumin Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| Drug |
G721R |
|