Fimasartan (BR-A-657) Multiple 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

NCT01289899

2290/9

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 multiple oral dose of BR-A-657 in healthy male subjects.

Full 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.

Enrollment

16 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

male of 18-55 years old
BMI 19-29kg/m2
subjects in good health
subjects with written informed consent

Exclusion criteria

subjects with multiple drug allergy or allergy to ARB
subjects with medication that affect drug absorption or elimination within 30days.
subjects with orthostatic hypotension of >20mmHg decrease of sbp
subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder