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The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.
Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin 1 | Experimental | Volunteers will be taken Tamsulosin and solifenacin |
|
| Solifenacin 1 | Experimental | Volunteers will be taken Tamsulosin and solifenacin |
|
| Co-administration 1 | Experimental | Volunteers will be taken Tamsulosin and solifenacin |
|
| Tamsulosin 2 | Experimental | Volunteers will be taken Tamsulosin and solifenacin |
|
| Solifenacin 2 | Experimental | Volunteers will be taken Tamsulosin and solifenacin |
|
| Co-administration 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss, Cmax,ss | 192h |
| Measure | Description | Time Frame |
|---|---|---|
| C trough,ss | 192h | |
| Tmax,ss | 192h | |
| t1/2 | 192h |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital(SNUH) | Seoul | Jongno-Gu | 110-744 | South Korea |
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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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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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Volunteers will be taken Tamsulosin and solifenacin |
|
|
| Solifenacin | Drug | Tamsulosin and solifenacin: Solifenacin 10 mg, once daily |
|
|
| Tamsulosin and solifenacin | Drug | Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily |
|
|
| CL/F | 192h |
| 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 |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |