The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic (PK/PD) of ascending single oral dose of BR-A-657 in healthy male subjects.
BR-A-657 20, 50, 120, 240, 360, 480mg or placebo were administered once to 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
40
20, 60, 120, 240, 360, 480mg or placebo tablet
No of subjects with Adverse events(AE) from each observations
1. AE reporting: Pre dose, 3, 12, 24h, (48 h: Groups C, D, E) post dose 2. Vital signs: Pre dose\*, 0.5, 1\*, 2, 4\*, 6, 8\*, 12 and 24\* h post dose (\*:both supine and standing) 3. ECG: Pre dose, 2, 4, 8 and 24 h post dose 4. Clinical laboratory examination: Pre dose and 24 h post dose 5. Physical examination: predose, 5\~7days post dose 6. Body weight: predose, 5\~7days post dose
Time frame: up to 5~7days post-dose
Area under the plasma concentration time curve (AUC)
Time frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Maximum observed plasma concentration (Cmax)
Time frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Time of the maximum observed plasma concentration (Tmax)
Time frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Apparent total plasma clearance (CL/F)
Time frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Apparent plasma terminal elimination half life (t½)
Time frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
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