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The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.
A randomized, open-label, single dose, two-way crossover study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JLP-1207, Fasted followed by fed | Experimental | JLP-1207 dosing in the fasted state followed by fed dosing |
|
| JLP-1207, Fed followed by fasted | Experimental | JLP-1207 dosing in the fed state followed by fasted dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JLP-1207(Fasted) | Drug | Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast, Cmax, AUCinf | 192 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | 192 hours | |
| t1/2 | 192 hours | |
| CL/F | 192 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-sang Yu, M.D., Ph.D. | Seoul National University Hospital(SNUH) | Principal Investigator |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| JLP-1207(Fed) | Drug | Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed condition |
|
| D052801 |
| Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |