Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects

BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects

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.

Inclusion Criteria:

• male of 18-55 years old
• BMI 19-29kg/m2
• subjects in good health
• subjects with written informed consent

Exclusion Criteria:

• subjects with multiple drug allergy or allergy to ARB
• subjects with medication that affect drug absorption or elimination within 30days.
• subjects with orthostatic hypotension of >20mmHg decrease of sbp
• subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder