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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in healthy male subjects.
BR-A-657 120, 360, or placebo were administered once daily for 7days to 16 healthy male subjects.
Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects.
PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | BR-A-657 120mg or placebo |
|
| Arm B | Experimental | BR-A-657 360mg or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR-A-657 | Drug | 120, 360mg or placebo 7days |
|
| Measure | Description | Time Frame |
|---|---|---|
| No of subjects with Adverse events(AE) from each observations |
| up to 5~7days post final(7th) dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration time curve (AUC) | predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 | |
| Maximum observed plasma concentration (Cmax). | predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E Engmann, MB ChB | Covance Clinical Research Unit | Principal Investigator |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
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| parent plasma terminal elimination half life (t½) | predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 |
| Apparent total plasma clearance (CL/F) | predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 |
| Accumulation ratio (RA) | RA1=Accumulation ratio based on AUCinf RA2=Accumulation ratio based on Cmax | predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 |