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To investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15, 30 and 60 mg after single oral administration in healthy Korean male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Single dose, Tolvaptan 15mg or Placebo/day |
|
| Arm 2 | Experimental | Single dose, Tolvaptan 30mg or Placebo/day |
|
| Arm 3 | Experimental | Single dose, Tolvaptan 60mg or Placebo/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan 15mg or 30mg or 60mg or Placebo | Drug | Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: AUC, Cmax, Tmax | 1 day | |
| PD parameters: 24 hour fluid balance | 1 day | |
| Safety: adverse event, body weight, physical examination, vital sign, ECG, clinical laboratory test | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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