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The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin 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 | Experimental | JLP-1207 dosing in the fed state(high fat meal) |
|
| Solifenacin 5mg+Tamsulosin 0.2mg | Experimental | Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JLP-1207 | Drug | The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast, Cmax | 192 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | 192 hours | |
| Tmax | 192 hours | |
| t1/2 | 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 |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D011470 | Prostatic Hyperplasia |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| Solifenacin 5mg+Tamsulosin 0.2mg | Drug | The subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition. |
|
| CL/F | 192 hours |
| Vd/f | 192 hours |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |