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The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397 in healthy male volunteers.
A randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the safety and pharmacokinetic profiles of CKD-397 in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-397 | Active Comparator | Tadalafil/ Tamsulosin Fixed dose combination |
|
| TD+TM | Experimental | Tadalafil/ Tamsulosin Coadministration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-397 | Drug | Arm A:Tamsulosin/ Tadalafil Fixed dose combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t of Tadalafil/ Tamsulosin | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Tadalafil/ Tamsulosin | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | |
| AUCinf of Tadalafil/ Tamsulosin | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Kyu Park, MD, PhD | 9F, DongA University Hospital Department of clinical pharmacology, #26, Daechingongwon-ro, seo-gu, busan, 49201, KOREA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong A University Hospital | Seo-gu | Busan | 49201 | South Korea |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| TD+TM | Drug | Arm B: Tamsulosin/ Tadalafil Coadministration |
|
|
| Tmax of Tadalafil/ Tamsulosin |
| 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours |
| t1/2 of Tadalafil/ Tamsulosin | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours |
| CL/F of Tadalafil/ Tamsulosin | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours |
| Vd/F of Tadalafil/ Tamsulosin | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours |
| D052801 |
| Male Urogenital Diseases |