NCT01289899

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (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 multiple oral dose of BR-A-657 in healthy male subjects.

Detailed description

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.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	BR-A-657	120, 360mg or placebo 7days

Timeline

• Start date: 2004-01-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2011-02-04
• Last updated: 2011-02-04