Overview

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

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Collaborator:
Covance
Criteria
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