Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects

Boryung

Status and phase: Completed; Phase 1

Conditions: Essential Hypertension

Treatments: Drug: BR-A-657

Study type: Interventional

Funder types: Industry

Identifiers

NCT01289886

2290/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 5 patient groups

Arm A

Other group

Description:

BR-A-657 20mg or placebo

Treatment:

Drug: BR-A-657

Arm B

Other group

Description:

BR-A-657 60mg or placebo

Treatment:

Drug: BR-A-657

Arm C

Other group

Description:

BR-A-657 120mg or placebo

Treatment:

Drug: BR-A-657

Arm D

Other group

Description:

BR-A-657 240mg or placebo

Treatment:

Drug: BR-A-657

Arm E

Other group

Description:

BR-A-657 480mg or placebo

Treatment:

Drug: BR-A-657