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This study is a randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the effects of food on the bioavailability of CKD-397 after a single oral dose in healthy male subjects
To healthy male subjects of sixteen(16), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.
Treatment A: CKD-397 1T under Fasting condition Treatment B: CKD-397 1T under Fed condition (high fat meals). Pharmacokinetic blood samples are collected up to 72hrs. Safety and pharmacokinetic are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | Experimental |
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| B group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-397 | Drug | CKD-397 1T single oral administration under fasting condition or fed condition(high fat meals) |
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| Measure | Description | Time Frame |
|---|---|---|
| AUClast of Tadalafil and Tamsulosin | 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs | |
| Cmax of Tadalafil and Tamsulosin | 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Tadalafil and Tamsulosin | 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs | |
| Tmax of Tadalafil and Tamsulosin | 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Kyu Park, MD, PhD | Domg-A University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Seo-gu | Busan | 602-715 | 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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| t1/2 of Tadalafil and Tamsulosin | 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs |
| CL/F of Tadalafil and Tamsulosin | 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs |
| Vd/F of Tadalafil and Tamsulosin | 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs |
| D052801 |
| Male Urogenital Diseases |