Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects
BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Single Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects Incorporating a Comparison of Fed/Fasted Pharmacokinetics
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.
20, 60, 120, 240, 360, 480mg or placebo tablet
Inclusion Criteria: male of 18-55 years old Body Mass Index(BMI) 19-29kg/m2 subjects in good health subjects with written informed consent Exclusion Criteria: subjects with multiple drug allergy or allergy to Angiotensin Receptor Blocker(ARB) subjects with medication that affect drug absorption or elimination within 30days. subjects with orthostatic hypotension of >20mmHg decrease of Systolic Blood Pressure(SBP) subjects with history of neurologic, liver, renal, gastrointestinal, cardiovascular, psychological or other major disorder