NCT01289886

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	BR-A-657	20, 60, 120, 240, 360, 480mg or placebo tablet

Timeline

• Start date: 2003-09-01
• Primary completion: 2003-11-01
• Completion: 2003-12-01
• First posted: 2011-02-04
• Last updated: 2011-02-04