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We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and both together in a 3 period repeatedly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Tadalafil→Tamsulosin→Tadalafil+Tamsulosin |
|
| Sequence 2 | Experimental | Tadalafil+Tamsulosin→Tadalafil→Tamsulosin |
|
| Sequence 3 | Experimental | Tamsulosin→Tadalafil+Tamsulosin→Tadalafil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil | Drug |
| ||
| Tamsulosin |
| Measure | Description | Time Frame |
|---|---|---|
| Tadalafil,Tamsulosin Cmax,ss | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) | |
| Tadalafil,Tamsulosin AUCÏ„ | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Tadalafil,Tamsulosin tmax,ss | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) | |
| Tadalafil,Tamsulosin t1/2 | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samgsung Seoul Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| Tadalafil + Tamsulosin | Drug |
|
| Tadalafil,Tamsulosin CL/Fss | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) |
| Tadalafil,Tamsulosin Vd/Fss | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) |
| Tadalafil,Tamsulosin Cav | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) |
| Tadalafil,Tamsulosin Cmin,ss | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D011469 | Prostatic Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-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 |