Trial | NCT01289886  Report issue

Title

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

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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
2003
Primary Completion
Nov 30
2003
Study Completion
Dec 31
2003
Last Update
Feb 04
2011
Estimate

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

Criteria 

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