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
  • Phase

    Phase 1
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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 Started
Sep 30
Primary Completion
Nov 30
Study Completion
Dec 31
Last Update
Feb 04

Drug BR-A-657

20, 60, 120, 240, 360, 480mg or placebo tablet

  • Other names: Fimasartan, 20, 60, 120, 240, 360, 480mg

Arm A Other

BR-A-657 20mg or placebo

Arm B Other

BR-A-657 60mg or placebo

Arm C Other

BR-A-657 120mg or placebo

Arm D Other

BR-A-657 240mg or placebo

Arm E Other

BR-A-657 480mg or placebo


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
No Results Posted