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To investigate the PK charateristics and the effect of food on the PK in healthy male volunteers who receive HIP1402 capsule in fed versus fasted condition
A randomized, open-label, single dose, three-way crossover clinical trial to investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of HIP1402 in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | High fat diet+HGP0412 → High fat diet+HIP1402 → fasted state+HIP1402 |
|
| Sequence 2 | Experimental | High fat diet+HIP1402 → fasted state+HIP1402 → High fat diet+HGP0412 |
|
| Sequence 3 | Experimental | fasted state+HIP1402 → High fat diet+HGP0412 → High fat diet+HIP1402 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIP1402 | Drug | Tamsulosin HCl 0.4mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tamsulosin, AUC(AUClast, AUCinf), | pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose | |
| Tamsulosin, Cmax | pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose | |
| Tamsulosin, Tmax | pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose | |
| Tamsulosin, t1/2 | pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose | |
| Tamsulosin, CL/F | pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose | |
| Tamsulosin, Vz/F | pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, M.D. | Seoul National University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33425801 | Derived | Ban MS, Kim YK, Kim B, Jung J, Kim YI, Oh J, Yu KS. Evaluation of the pharmacokinetics and food effects of a novel formulation tamsulosin 0.4 mg capsule compared with a 0.2 mg capsule in healthy male volunteers. Transl Clin Pharmacol. 2020 Dec;28(4):181-188. doi: 10.12793/tcp.2020.28.e17. Epub 2020 Nov 24. |
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| HGP0412 |
| Drug |
Tamsulosin HCl 0.2mg |
|